Known or Highly Suspected Central Nervous System (CNS) LesionPhase 2/3LUMINANCT07472491
A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients
A Phase 2/3 study testing Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL, MRI Scan and Gadobutrol in people with Known or Highly Suspected Central Nervous System (CNS) Lesion and Known or Highly Suspected Body (Excluding CNS) Lesion, run by GE Healthcare at 7 sites in 4 countries.
Trial summary
This is an operationally combined Phase 2/3 study, which will be conducted and evaluated in 2 distinct parts: Phase 2: Prospective, adaptive, multicenter, non-randomized, single-blind, dose-finding, including participants with known or highly suspected lesions of the CNS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Known or Highly Suspected Central Nervous System (CNS) Lesion, Known or Highly Suspected Body (Excluding CNS) Lesion
- What is being tested?
- Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL, MRI Scan and Gadobutrol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 1 Apr 2026to 30 Nov 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant is of legal majority age, as defined by local laws and regulations at the time of signing the ICF.
- The participant is able and willing to comply with study procedures as described in the protocol.
- The participant has read, understood, signed and dated the ICF prior to any study procedures.
- Phases 2 and 3 CNS: Participants presenting with known or highly suspected enhancing CNS lesions referred as part of standard care for contrast-enhancing MRI of the CNS. The suspicion may be based on a previous imaging procedure such as computed tomography (CT), positron emission tomography (PET)/CT or MRI performed within 12 months prior to ICF signature.
- Phase 3 body only: Participants presenting with known or highly suspected enhancing lesions in at least 1 body region (i.e., head and neck, thorax, abdomen, pelvis, and musculoskeletal system [only breast in the United States in compliance with local approved indications of gadobutrol]) referred as part of standard care for contrast-enhancing MRI of the body. The suspicion may be based on a previous imaging procedure such as CT, PET/CT, ultrasound or MRI performed within 12 months prior to ICF signature.
- The participant is scheduled for a contrast-enhanced MRI examination of the CNS or a body region for clinical reasons and has agreed to have a second contrast-enhanced MRI examination for the purpose of this study.
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- The participant is in a clinically stable condition (i.e., no acute deterioration within 48 hours before enrollment).
- Female Participants: The participant is a female who is either surgically sterile (has had a documented bilateral oophorectomy, bilateral salpingectomy, and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or non-lactating, or if of childbearing potential the results of a serum human chorionic gonadotropin pregnancy test, performed at screening and the results of a urine pregnancy test, or serum human chorionic gonadotropin pregnancy test performed prior to each administration of IMP (with the result known before IMP administration), must be negative. Female participants of childbearing potential must agree to use adequate contraception and not harvest or donate eggs from screening until 30 days after final dose of IMP. Such methods include hormonal contraception including oral, intravaginal, transdermal, injectable, and implantable contraceptives; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner. Total abstinence, in accordance with the lifestyle of the participant, is also acceptable.
- Male Participants: The participant is a male who is surgically sterile (vasectomy or bilateral orchidectomy), a male who is sexually active with a partner who is not of childbearing potential, or a male who is sexually active with a partner of childbearing potential who must agree to use adequate contraception and not harvest or donate sperm from screening until 90 days after final dose of IMP. Adequate contraception for the male participant (and any female partner, if she is of childbearing potential) is defined as using hormonal contraception (including oral, intravaginal, transdermal, injectable or implantable contraceptives), an intrauterine device, or an intrauterine hormone-releasing system, combined with at least one of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence, in accordance with the lifestyle of the participant, is also acceptable.
Who cannot join
- The participant has previously enrolled in this mangaciclanol study, including participation in an earlier phase or cohort.
- The participant has a contraindication to MRI examination, such as the presence of a cardiac pacemaker or other electronic devices, presence of ferromagnetic metal foreign bodies in vulnerable positions or within positions that would affect the imaged field of view, presence of certain tattoos that may raise a safety concern for MRI, participant suffering from severe claustrophobia which is not manageable with standard sedation, or participant working as a machinist, welder or metal worker (unless the participant will undergo thorough screening by radiology personnel to rule out the presence of metallic foreign bodies, especially in or near the eyes).
- Participant with severe cardiovascular disease (e.g., known long QT syndrome including QTc prolongation based on screening ECG, acute myocardial infarction within the past 14 days, unstable angina, congestive heart failure class III/IV by New York Heart Association classification, or acute stroke within the past 48 hours).
- (Phase 2 only) Participant with an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) within 14 days prior to the first IMP administration.
- (Phase 3 only) Participant with an eGFR <30 mL/min/1.73m2 calculated using the CKD-EPI within 14 days prior to the first IMP administration.
- Participant with increased likelihood of hypersensitivity specifically to mangaciclanol, gadolinium or a component of the formulation.
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- Participant has received any non-study contrast agent within 72 hours prior to the first study MRI, or is planning to receive any non-study contrast agent during the trial until 24 ± 4 hours after the second study MRI.
- Participant has received any investigational product within 30 days or within 5 times the half-life of that drug, whichever is shorter, prior to or concurrent with this study.
- Participant is expected/scheduled to have any treatment or medical procedure (e.g., chemotherapy, radiotherapy, biopsy, resection, etc.) that may impact aspects of the imaged lesions from the first study MRI up to 24 hours after the second study MRI. (Participants under corticosteroids and/or maintenance chemotherapy with a stable dose at the time of screening visit and throughout the trial can be included).
- Participant may not be able to complete the study, based on their anticipated life expectancy, or where study participation may compromise the management of the participant, or any other reason that in the judgment of the investigator makes the participant unsuitable for participation in the study.
- Participant is pregnant or planning to become pregnant, or breast-feeding.
- Participant is unable or unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and/or considered unlikely to complete the trial.
Trial locations and contacts
7 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Catherine Copse contact
7 sites in 4 countries
Georgia3 sites, 3 recruiting
- Recruiting
LTD Israel-Georgian Medical Research Clinic Healthycore
Tbilisi, 0112
- Recruiting
LTD New Hospitals
Tbilisi, 0114
- Recruiting
LLC Todua Clinic
Tbilisi, 0119
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
Renovatio Clinical
The Woodlands, Texas, 77380
Moldova1 site, 1 recruiting
- Recruiting
Arensia Exploratory Medicine - Moldova - IMSP Spitalul Clinic Republican Timofei Mosneaga
Chisinau, MD-2025
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
About this study
Official title: A Prospective, Multicenter Phase 2/3 Study to Assess the Efficacy and Safety of Mangaciclanol in Adult Patients With Known or Highly Suspected Lesions Referred for Contrast-Enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) or Body (LUMINA)
This is an operationally combined Phase 2/3 study, which will be conducted and evaluated in 2 distinct parts:
- Phase 2: Prospective, adaptive, multicenter, non-randomized, single-blind, dose-finding, including participants with known or highly suspected lesions of the CNS. The aim of the Phase 2 part is to identify an optimized dose of mangaciclanol for the Phase 3 part of the study.
- Phase 3: Prospective, multicenter, randomized, controlled, single-blind, cross-over, including participants with known or highly suspected lesions of the CNS or body. The aim of the Phase 3 part is to further evaluate the efficacy and safety of mangaciclanol-enhanced MRI for the detection and characterization of lesions of the CNS or body.
Read more
The investigational medicinal products (IMPs) used during the trial are mangaciclanol and gadobutrol (comparator IMP).
Primary and key secondary efficacy analyses will be based on independent central blinded image evaluation (BIE), and Phase 2 data will be analyzed prior to commencement of Phase 3.
- Conditions
- Known or Highly Suspected Central Nervous System (CNS) Lesion, Known or Highly Suspected Body (Excluding CNS) Lesion
- Being tested
- Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL, MRI Scan, Gadobutrol
- Keywords
- Contrast-enhanced magnetic resonance imaging (MRI), Mn-based contrast agents (MBCAs), Gd-based contrast agents (GBCAs), Lesion visualization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mLDrug
Single intravenous (IV) administration of Mangaciclanol (GEH200486 Injection, 0.5 mmol/mL) followed by a 20mL saline flush
MRI ScanDiagnostic test
MRI Scan starting prior to IMP administration and continuing for up to 60 minutes post IMP administration
GadobutrolDrug
Single intravenous (IV) administration of Gadobutrol (0.1 mmol/kg) followed by a 20mL saline flush
| Study group | Role | What they receive |
|---|---|---|
| Phase 2 | Active comparator | An initial dose of 0.1 mmol/kg mangaciclanol will be compared to the standard dose of gadobutrol (0.1 mmol/kg) in Cohort 1, in approximately 60 participants.
A second cohort (Cohort 2) may be initiated based on the outcome of the analysis of Cohort 1. This cohort will include approximately 60 participants (higher or lower dose), or 30 participants (same dose), depending on the dose of mangaciclanol selected for further evaluation. Receives: Drug: Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL; Diagnostic Test: MRI Scan; Drug: Gadobutrol |
| Phase 3 mangaciclanol-gadobutrol | Active comparator | Participants with known or highly suspected lesions of CNS or body, randomized to receive treatment sequence mangaciclanol (V2) followed by gadobutrol (V4) Receives: Drug: Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL; Diagnostic Test: MRI Scan; Drug: Gadobutrol |
| Phase 3 gadobutrol-mangaciclanol | Active comparator | Participants with known or highly suspected lesions of CNS or body, randomized to receive treatment sequence gadobutrol (V2) followed by mangaciclanol (V4) Receives: Drug: Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL; Diagnostic Test: MRI Scan; Drug: Gadobutrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 2 Primary Endpoint - Overall diagnostic preference
Overall diagnostic preference based on global matched pairs reads according to a 3-point scale that is derived from a 5-point scale (1 = greatly prefer mangaciclanol/prefer mangaciclanol, 0 = no preference, -1 = prefer gadobutrol/greatly prefer gadobutrol), as evaluated by 3 blinded independent readers.
Measured: 4-47 days
Phase 3 Primary Endpoint - Lesion visualization criteria
Lesion visualization criteria (lesion border delineation, internal morphology and degree of lesion contrast enhancement) for paired (unenhanced plus mangaciclanol-enhanced) MRIs compared to unenhanced MRI based on the primary reads on a 4-point scale (1 = poor / none; 2 = moderate; 3 = good; 4 = excellent) for up to 3 of the most representative lesions.
Measured: 4-74 days
Secondary outcomes (44)
Phase 2 Secondary Endpoint - Lesion visualization criteria
Lesion visualization criteria (lesion border delineation, internal morphology, and degree of lesion contrast enhancement) on a 4-point scale (1 = poor / none; 2 = moderate; 3 = good; 4 = excellent) for up to 3 of the most representative lesions based on the primary reads.
Measured: 4-47 days
Phase 2 Secondary Endpoint - Number of lesions
Number of lesions based on global matched pairs reads and primary reads, and size and location of up to 3 of the most representative lesions based on the primary reads.
Measured: 4-47 days
Phase 2 Secondary Endpoint - Technical adequacy of images for diagnosis
Technical adequacy of images for diagnosis according to categorical assessment of image quality based on the primary reads.
Measured: 4-47 days
Phase 2 Secondary Endpoint - Contrast enhancement percentage (CE%)
Quantitative measurements of percentage of contrast enhancement (CE%) between unenhanced and contrast-enhanced images, will be determined per participant as the average for up to 3 of the most representative lesions (i.e., the same lesions identified for assessment of lesion visualization scores) based on evaluation of paired (unenhanced and contrast-enhanced) images
Measured: 4-47 days
Phase 2 Secondary Endpoint - contrast-to-noise ratio (CNR)
Quantitative measurements of contrast-to-noise ratio (CNR) and change in CNR (ΔCNR) between unenhanced and contrast-enhanced images, will be determined per participant as the average for up to 3 of the most representative lesions (i.e., the same lesions identified for assessment of lesion visualization scores) based on evaluation of paired (unenhanced and contrast-enhanced) images.
Measured: 4-47 days
Phase 2 Secondary Endpoint - signal-to-noise ratio (SNR)
Quantitative measurements of signal-to-noise ratio (SNR) will be determined per participant as the average for up to 3 of the most representative lesions (i.e., the same lesions identified for assessment of lesion visualization scores) based on evaluation of paired (unenhanced and contrast-enhanced) images.
Measured: 4-47 days
Phase 2 Secondary Endpoint - Intra-reader reproducibility regarding overall diagnostic preference (primary endpoint).
Intra-reader reproducibility (from 10% re-read) will be analyzed for overall diagnostic preference according to a 3-point scale (as nominal response) and a 5-point scale (as ordinal response with linear relationship).
Measured: 4-47 days
Phase 2 Secondary Endpoint - Inter-reader agreement regarding overall diagnostic preference (primary endpoint).
Inter-reader agreement will be analyzed for overall diagnostic preference according to a 3-point scale (as nominal response) and a 5-point scale (as ordinal response with linear relationship).
Measured: 4-47 days
Phase 2 Secondary Endpoint - Incidence of TEAEs
Incidence of treatment-emergent adverse events (TEAEs).
Measured: 4-47 days
Number and percentage of participants with changes from baseline in serum biochemistry laboratory test results
Absolute value and change from pre-MRI in serum biochemistry laboratory test results
Measured: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in hematology laboratory test results
Absolute value and change from pre-MRI in hematology laboratory test results.
Measured: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in urinalysis test results
Absolute value and change from pre-MRI in urinalysis test results.
Measured: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in systolic and diastolic blood pressure
Absolute value and change from pre-MRI in systolic and diastolic blood pressure in millimeters of mercury.
Measured: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in respiratory rate
Absolute value and change from pre-MRI in respiratory rate (breaths per minute).
Measured: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in heart rate
Absolute value and change from pre-MRI in heart rate (beats per minute).
Measured: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in temperature
Absolute value and change from pre-MRI in temperature (degrees Celsius).
Measured: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in electrocardiogram examinations
Absolute value and change from pre-MRI in electrocardiogram examinations (PR, QRS, and QTcF).
Measured: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in physical examination findings
Absolute value and change from pre-MRI in physical examination findings.
Measured: 4-47 days
Phase 2 Secondary Endpoint - Incidence of abnormal safety parameters
Incidence of abnormal vital signs, 12-lead ECG, physical examination, clinical laboratory parameters, and urinalysis results.
Measured: 4-47 days
Phase 3 Secondary Endpoints - Lesion Visualization
Lesion visualization criteria (lesion border delineation, internal morphology, and degree of contrast enhancement) for paired (unenhanced and contrast-enhanced) MRIs based on primary reads of images acquired with mangaciclanol as compared to gadobutrol, according to a 4-point scale for up to 3 of the most representative lesions.
Measured: 4-74 days
Phase 3 Secondary Endpoints - Overall diagnostic preference based on global matched pairs reads
Overall diagnostic preference based on global matched pairs reads according to a 3-point scale that is derived from a 5-point scale (1 = greatly prefer/prefer mangaciclanol; 0 = no preference; ˗1 = greatly prefer/prefer gadobutrol), as evaluated by 3 blinded independent readers.
Measured: 4-74 days
Phase 3 Secondary Endpoints - Number of lesions
Number of lesions based on global matched pairs reads, on-site investigator reads and primary reads, and size and location of up to 3 of the most representative lesions based on primary reads and on-site investigator reads.
Measured: 4-74 days
Phase 3 Secondary Endpoints - Technical adequacy of images for diagnosis
Technical adequacy of images for diagnosis according to a categorical assessment of image quality based on the primary reads and the on-site investigator reads will be described only in terms of number and percentage of participants.
Measured: 4-74 days
Phase 3 Secondary Endpoints - Patient diagnosis and diagnostic confidence
Patient diagnosis and diagnostic confidence according to a 5-point scale (nil, poor, moderate, high, excellent) based on primary reads and on-site investigator reads.
Measured: 4-74 days
Phase 3 Secondary Endpoints - Contrast enhancement percentage (CE%)
Quantitative measurements of percentage of contrast enhancement (CE%) between unenhanced and contrast-enhanced images, will be determined per participant as the average for up to 3 of the most representative lesions (i.e., the same lesions identified for assessment of lesion visualization scores) based on evaluation of paired (unenhanced and contrast-enhanced) images.
Measured: 4-74 days
Phase 3 Secondary Endpoints - contrast-to-noise ratio (CNR)
Quantitative measurements of contrast-to-noise ratio (CNR) and change in CNR (ΔCNR) between unenhanced and contrast-enhanced images, will be determined per participant as the average for up to 3 of the most representative lesions (i.e., the same lesions identified for assessment of lesion visualization scores) based on evaluation of paired (unenhanced and contrast-enhanced) images.
Measured: 4-74 days
Phase 3 Secondary Endpoints - signal-to-noise ratio (SNR)
Quantitative measurements of signal-to-noise ratio (SNR) will be determined per participant as the average for up to 3 of the most representative lesions (i.e., the same lesions identified for assessment of lesion visualization scores) based on evaluation of paired (unenhanced and contrast-enhanced) images.
Measured: 4-74 days
Phase 3 Secondary Endpoints - Lesion visualization criteria
Lesion visualization criteria for unenhanced and paired (unenhanced and contrast-enhanced) MRIs based on the on-site investigator (radiologists) reads for up to 3 of the most representative lesions.
Measured: 4-74 days
Phase 3 Secondary Endpoints - Per-lesion sensitivity
Per-lesion sensitivity of mangaciclanol-enhanced and gadobutrol-enhanced MRI for detection of malignancy, based on histopathological reference standard
Measured: 4-74 days
Phase 3 Secondary Endpoints - Per-lesion specificity
Per-lesion specificity of mangaciclanol-enhanced and gadobutrol-enhanced MRI for detection of malignancy, based on histopathological reference standard
Measured: 4-74 days
Phase 3 Secondary Endpoints - The impact on patient treatment plan
The impact on patient treatment plan (yes/no; including resection, biopsy, chemotherapy, radiotherapy, other specified treatment) as assessed by the on-site investigator for each contrast agent.
Measured: 4-74 days
Phase 3 Secondary Endpoints - Intra-reader reproducibility regarding lesion visualization criteria (primary endpoint)
Intra-reader reproducibility will be evaluated for lesion visualization criteria (lesion border delineation, internal morphology and degree of contrast enhancement) for each treatment using a Bland-Altman plot for absolute agreement on a subset of participants with re-reads (10%). Descriptive statistics will be provided for the first vs. second measurement, as well as for the minimum vs. maximum values. Additionally, descriptive statistics will be presented for the absolute value of the paired differences between the 2 measurements.
Measured: 4-74 days
Phase 3 Secondary Endpoints - Inter-reader agreement regarding lesion visualization criteria (primary endpoint)
Inter-reader agreement will be analyzed using both a 2-way random effect model for consistency and absolute agreement to calculate intraclass correlation coefficients.
Measured: 4-74 days
Phase 3 Secondary Endpoints - Incidence of participants with at least 1 new lesion detected
Incidence of participants with at least 1 new lesion detected on paired MRI compared to unenhanced MRI based on global matched pairs reads.
Measured: 4-74 days
Phase 3 Secondary Endpoints - Incidence of Treatment Emergent Adverse Events (TEAEs)
Incidence of TEAEs.
Measured: 4-74 days
Phase 3 Secondary Endpoints - Number and percentage of participants with changes from baseline in serum biochemistry laboratory test results
Absolute value and change from pre-MRI serum biochemistry laboratory test results.
Measured: 4-74 days
Phase 3 Secondary Endpoint - Number and percentage of participants with changes from baseline in hematology laboratory test results
Absolute value and change from pre-MRI in hematology laboratory test results.
Measured: 4-74 days
Phase 3 Secondary Endpoint - Number and percentage of participants with changes from baseline in urinalysis test results
Absolute value and change from pre-MRI in urinalysis test results.
Measured: 4-74 days
Phase 3 Secondary Endpoint - Number and percentage of participants with changes from baseline in systolic and diastolic blood pressure
Absolute value and change from pre-MRI in systolic and diastolic blood pressure in millimeters of mercury.
Measured: 4-74 days
Phase 3 Secondary Endpoint - Number and percentage of participants with changes from baseline in respiratory rate
Absolute value and change from pre-MRI in respiratory rate (breaths per minute).
Measured: 4-74 days
Phase 3 Secondary Endpoint - Number and percentage of participants with changes from baseline in heart rate
Absolute value and change from pre-MRI in heart rate (beats per minute).
Measured: 4-74 days
Phase 3 Secondary Endpoint - Number and percentage of participants with changes from baseline in temperature
Absolute value and change from pre-MRI in temperature (degrees Celsius).
Measured: 4-74 days
Phase 3 Secondary Endpoint - Number and percentage of participants with changes from baseline in physical examination findings
Absolute value and change from pre-MRI in physical examination findings.
Measured: 4-74 days
Phase 3 Secondary Endpoints - Incidence of abnormal safety parameters
Incidence of abnormal vital signs, physical examination, clinical laboratory parameters, and urinalysis results.
Measured: 4-74 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Apr 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Known or Highly Suspected Central Nervous System (CNS) LesionStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephanie Van de Ven, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472491
- Sponsor's protocol ID
- GE-227-203
- Other IDs
- 2025-523862-25-00, 2025
- Acronym
- LUMINA
- Status last verified
- Apr 2026
- First submitted
- 12 Feb 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Phase 2/3 Study to Assess the Efficacy and Safety of Mangaciclanol in Adult Patients With Known or Highly Suspected Lesions Referred for Contrast-Enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) or Body (LUMINA)
- ClinicalTrials.gov ID
- NCT07472491
- Acronym / sponsor ID
- LUMINA / GE-227-203
- Conditions
- Known or Highly Suspected Central Nervous System (CNS) Lesion, Known or Highly Suspected Body (Excluding CNS) Lesion
- Keywords
- Contrast-enhanced magnetic resonance imaging (MRI), Mn-based contrast agents (MBCAs), Gd-based contrast agents (GBCAs), Lesion visualization
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an operationally combined Phase 2/3 study, which will be conducted and evaluated in 2 distinct parts:
- Phase 2: Prospective, adaptive, multicenter, non-randomized, single-blind, dose-finding, including participants with known or highly suspected lesions of the CNS. The aim of the Phase 2 part is to identify an optimized dose of mangaciclanol for the Phase 3 part of the study.
- Phase 3: Prospective, multicenter, randomized, controlled, single-blind, cross-over, including participants with known or highly suspected lesions of the CNS or body. The aim of the Phase 3 part is to further evaluate the efficacy and safety of mangaciclanol-enhanced MRI for the detection and characterization of lesions of the CNS or body.
The investigational medicinal products (IMPs) used during the trial are mangaciclanol and gadobutrol (comparator IMP).
Primary and key secondary efficacy analyses will be based on independent central blinded image evaluation (BIE), and Phase 2 data will be analyzed prior to commencement of Phase 3.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 2 | Active comparator | Drug: Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL, Diagnostic Test: MRI Scan, Drug: GadobutrolAn initial dose of 0.1 mmol/kg mangaciclanol will be compared to the standard dose of gadobutrol (0.1 mmol/kg) in Cohort 1, in approximately 60 participants. A second cohort (Cohort 2) may be initiated based on the outcome of the analysis of Cohort 1. This cohort will include approximately 60 participants (higher or lower dose), or 30 participants (same dose), depending on the dose of mangaciclanol selected for further evaluation. |
| Phase 3 mangaciclanol-gadobutrol | Active comparator | Drug: Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL, Diagnostic Test: MRI Scan, Drug: GadobutrolParticipants with known or highly suspected lesions of CNS or body, randomized to receive treatment sequence mangaciclanol (V2) followed by gadobutrol (V4) |
| Phase 3 gadobutrol-mangaciclanol | Active comparator | Drug: Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL, Diagnostic Test: MRI Scan, Drug: GadobutrolParticipants with known or highly suspected lesions of CNS or body, randomized to receive treatment sequence gadobutrol (V2) followed by mangaciclanol (V4) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The participant is of legal majority age, as defined by local laws and regulations at the time of signing the ICF.
- The participant is able and willing to comply with study procedures as described in the protocol.
- The participant has read, understood, signed and dated the ICF prior to any study procedures.
- Phases 2 and 3 CNS: Participants presenting with known or highly suspected enhancing CNS lesions referred as part of standard care for contrast-enhancing MRI of the CNS. The suspicion may be based on a previous imaging procedure such as computed tomography (CT), positron emission tomography (PET)/CT or MRI performed within 12 months prior to ICF signature.
- Phase 3 body only: Participants presenting with known or highly suspected enhancing lesions in at least 1 body region (i.e., head and neck, thorax, abdomen, pelvis, and musculoskeletal system [only breast in the United States in compliance with local approved indications of gadobutrol]) referred as part of standard care for contrast-enhancing MRI of the body. The suspicion may be based on a previous imaging procedure such as CT, PET/CT, ultrasound or MRI performed within 12 months prior to ICF signature.
Key exclusion criteria (12 listed)
- The participant has previously enrolled in this mangaciclanol study, including participation in an earlier phase or cohort.
- The participant has a contraindication to MRI examination, such as the presence of a cardiac pacemaker or other electronic devices, presence of ferromagnetic metal foreign bodies in vulnerable positions or within positions that would affect the imaged field of view, presence of certain tattoos that may raise a safety concern for MRI, participant suffering from severe claustrophobia which is not manageable with standard sedation, or participant working as a machinist, welder or metal worker (unless the participant will undergo thorough screening by radiology personnel to rule out the presence of metallic foreign bodies, especially in or near the eyes).
- Participant with severe cardiovascular disease (e.g., known long QT syndrome including QTc prolongation based on screening ECG, acute myocardial infarction within the past 14 days, unstable angina, congestive heart failure class III/IV by New York Heart Association classification, or acute stroke within the past 48 hours).
- (Phase 2 only) Participant with an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) within 14 days prior to the first IMP administration.
- (Phase 3 only) Participant with an eGFR <30 mL/min/1.73m2 calculated using the CKD-EPI within 14 days prior to the first IMP administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mLSingle intravenous (IV) administration of Mangaciclanol (GEH200486 Injection, 0.5 mmol/mL) followed by a 20mL saline flush | Drug | Phase 2, Phase 3 gadobutrol-mangaciclanol, Phase 3 mangaciclanol-gadobutrol |
| MRI ScanMRI Scan starting prior to IMP administration and continuing for up to 60 minutes post IMP administration | Diagnostic test | Phase 2, Phase 3 gadobutrol-mangaciclanol, Phase 3 mangaciclanol-gadobutrol |
| GadobutrolSingle intravenous (IV) administration of Gadobutrol (0.1 mmol/kg) followed by a 20mL saline flush | Drug | Phase 2, Phase 3 gadobutrol-mangaciclanol, Phase 3 mangaciclanol-gadobutrol |
Primary outcome
Phase 2 Primary Endpoint - Overall diagnostic preference
Time frame: 4-47 days
Overall diagnostic preference based on global matched pairs reads according to a 3-point scale that is derived from a 5-point scale (1 = greatly prefer mangaciclanol/prefer mangaciclanol, 0 = no preference, -1 = prefer gadobutrol/greatly prefer gadobutrol), as evaluated by 3 blinded independent readers.
Phase 3 Primary Endpoint - Lesion visualization criteria
Time frame: 4-74 days
Lesion visualization criteria (lesion border delineation, internal morphology and degree of lesion contrast enhancement) for paired (unenhanced plus mangaciclanol-enhanced) MRIs compared to unenhanced MRI based on the primary reads on a 4-point scale (1 = poor / none; 2 = moderate; 3 = good; 4 = excellent) for up to 3 of the most representative lesions.
44 secondary outcomes
Phase 2 Secondary Endpoint - Lesion visualization criteria
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Number of lesions
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Technical adequacy of images for diagnosis
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Contrast enhancement percentage (CE%)
Time frame: 4-47 days
Phase 2 Secondary Endpoint - contrast-to-noise ratio (CNR)
Time frame: 4-47 days
Phase 2 Secondary Endpoint - signal-to-noise ratio (SNR)
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Intra-reader reproducibility regarding overall diagnostic preference (primary endpoint).
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Inter-reader agreement regarding overall diagnostic preference (primary endpoint).
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Incidence of TEAEs
Time frame: 4-47 days
Number and percentage of participants with changes from baseline in serum biochemistry laboratory test results
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in hematology laboratory test results
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in urinalysis test results
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in systolic and diastolic blood pressure
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in respiratory rate
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in heart rate
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in temperature
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in electrocardiogram examinations
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in physical examination findings
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Incidence of abnormal safety parameters
Time frame: 4-47 days
Phase 3 Secondary Endpoints - Lesion Visualization
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Overall diagnostic preference based on global matched pairs reads
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Number of lesions
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Technical adequacy of images for diagnosis
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Patient diagnosis and diagnostic confidence
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Contrast enhancement percentage (CE%)
Time frame: 4-74 days
Phase 3 Secondary Endpoints - contrast-to-noise ratio (CNR)
Time frame: 4-74 days
Phase 3 Secondary Endpoints - signal-to-noise ratio (SNR)
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Lesion visualization criteria
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Per-lesion sensitivity
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Per-lesion specificity
Time frame: 4-74 days
Phase 3 Secondary Endpoints - The impact on patient treatment plan
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Intra-reader reproducibility regarding lesion visualization criteria (primary endpoint)
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Inter-reader agreement regarding lesion visualization criteria (primary endpoint)
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Incidence of participants with at least 1 new lesion detected
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Number and percentage of participants with changes from baseline in serum biochemistry laboratory test results
Time frame: 4-74 days
Phase 3 Secondary Endpoint - Number and percentage of participants with changes from baseline in hematology laboratory test results
Time frame: 4-74 days
Phase 3 Secondary Endpoint - Number and percentage of participants with changes from baseline in urinalysis test results
Time frame: 4-74 days
Phase 3 Secondary Endpoint - Number and percentage of participants with changes from baseline in systolic and diastolic blood pressure
Time frame: 4-74 days
Phase 3 Secondary Endpoint - Number and percentage of participants with changes from baseline in respiratory rate
Time frame: 4-74 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catherine Copse contact
Stephanie Van de Ven study director
GE Healthcare
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL, MRI Scan and Gadobutrol in people with Known or Highly Suspected Central Nervous System (CNS) Lesion and Known or Highly Suspected Body (Excluding CNS) Lesion, run by GE Healthcare at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Georgia, United States, Moldova, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jay Chahal (+44 7786702088, jay.chahal@gehealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 2 Primary Endpoint - Overall diagnostic preference (time frame: 4-47 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.