Lesion in Body RegionPhase 3PROMISENCT03986138
Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)
A Phase 3 study testing gadopiclenol and Gadobutrol 1 MMOLE/ML Intravenous Solution in people with Lesion in Body Region, run by Guerbet at 33 sites in 11 countries.
Trial summary
The trial aimed at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lesion in Body Region
- What is being tested?
- gadopiclenol and Gadobutrol 1 MMOLE/ML Intravenous Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 33 sitesin 11 countries
- Study dates
- 27 Aug 2019to 9 Dec 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient presenting with known or suspected enhancing abnormality(ies) and/or lesion(s) in at least one body region based on a previous imaging procedure performed within 12 months prior to ICF signature. US patients are restricted to the breast in compliance with local approved indications of gadobutrol.
Who cannot join
- Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m² assessed within 1 day prior to each contrast agent administration.
Trial locations and contacts
33 sites in 11 countries.
33 sites in 11 countries
United States7 sites
The University of Alabama at Birmingham
Birmingham, Alabama, 35249
Boston Medical Center
Boston, Massachusetts, 02118
The University of Chicago Medical Center
Chicago, Illinois, 60637
University of Missouri Health System
Columbia, Missouri, 65212
UConn Health - University of Connecticut
Farmington, Connecticut, 06030-2802
UT Health San Antonio
San Antonio, Texas, 78207
Montefiore Medical Center
The Bronx, New York, 10467
Poland5 sites
Szpital Uniwersytecki Nr 1 im. dr Antoniego Jurasza w Bydgoszczy
Bydgoszcz
Uniwersyteckie Centrum Kliniczne
Gdansk
Jagiellońskie Centrum Innowacji Sp. z o. o.
Krakow
Szpital Świętego Rafała
Krakow
Centrum Medyczne Affidea Wałbrzych
Wałbrzych
South Korea5 sites
Inje University Busan Paik Hospital
Busan
Bucheon Suncheonhyang Hospital
Gyeonggi-do
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Germany4 sites
Klinik für Diagnostische und Interventionelle Radiologie
Aachen
Universitätsklinikum Halle
Halle
Universitätsklinikum des Saarlandes
Homburg
University Hospital Jena
Jena
Hungary2 sites
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok
Mexico2 sites
Clinical Research Institute S.C.
Estado de México
Axis Heilsa S de R.L. de C.V - Althian Clinical Research Management Center
Monterrey
About this study
The trial aimed at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)
Read the detailed description
The purpose of this trial was to evaluate a new gadolinium-based contrast agent (GBCA) gadopiclenol in terms of lesion visualization in patients referred for contrast-enhanced MRI of body regions.
This is a prospective, international, multi-center, randomized, double-blind, controlled and cross-over trial.
This trial was conducted in 33 centers worldwide. During the course of the trial, two MRIs were obtained from each patient: one with gadopiclenol and one with gadobutrol. MRI evaluations were assessed by independent off-site blinded readers.
- Conditions
- Lesion in Body Region
- Being tested
- gadopiclenol, Gadobutrol 1 MMOLE/ML Intravenous Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gadopiclenolDrug
Single intravenous bolus injection
Gadobutrol 1 MMOLE/ML Intravenous SolutionDrug
Single intravenous bolus injection
| Study group | Role | What they receive |
|---|---|---|
| gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI | Experimental | Cross-over design: each patient receives gadopiclenol for the first MRI and then gadobutrol for the second MRI Receives: Drug: gadopiclenol; Drug: Gadobutrol 1 MMOLE/ML Intravenous Solution |
| gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI | Experimental | Cross-over design: each patient receives gadobutrol for the first MRI and then gadopiclenol for the second MRI Receives: Drug: gadopiclenol; Drug: Gadobutrol 1 MMOLE/ML Intravenous Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI
The lesion visualization at patient level was based on 3 co-primary criteria on marching lesions: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor [internal morphology] or none [border delineation, contrast enhancement], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each co-criterion was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between Paired [unenhanced and contrast-enhanced] images and Pre-contrast [unenhanced] images was calculated for each of the 3 co-primary criteria and for each reader.
Measured: At first MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 1. At second MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 2, performed 2-14 days after gadobutrol-enhanced MRI.
Secondary outcomes (1)
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI
The lesion visualization (per patient) was based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement, assessed on the images performed with gadopiclenol and images performed with gadobutrol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor [internal morphology] or none [border delineation, contrast enhancement], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each of the 3 lesion visualization co-criteria was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between gadopiclenol scores mean and gadobutrol scores mean was calculated for each of the 3 co-primary criteria and for each reader.
Measured: At each of two MRI examinations with an interval of 2-14 days between two MRI examinations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start27 Aug 2019
- Primary completion9 Dec 2020
- Study completion9 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lesion in Body RegionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986138
- Sponsor's protocol ID
- GDX-44-011
- Acronym
- PROMISE
- Status last verified
- Sep 2025
- First submitted
- 11 Jun 2019
- Last updated
- 27 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuhl C, Csoszi T, Piskorski W, Miszalski T, Lee JM, Otto PM. Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI. Radiology. 2023 Jul;308(1):e222612. doi: 10.1148/radiol.222612.
PubMed 37462494
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)
- ClinicalTrials.gov ID
- NCT03986138
- Acronym / sponsor ID
- PROMISE / GDX-44-011
- Conditions
- Lesion in Body Region
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Posted 27 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial aimed at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)
Detailed description
The purpose of this trial was to evaluate a new gadolinium-based contrast agent (GBCA) gadopiclenol in terms of lesion visualization in patients referred for contrast-enhanced MRI of body regions.
This is a prospective, international, multi-center, randomized, double-blind, controlled and cross-over trial.
This trial was conducted in 33 centers worldwide. During the course of the trial, two MRIs were obtained from each patient: one with gadopiclenol and one with gadobutrol. MRI evaluations were assessed by independent off-site blinded readers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI | Experimental | Drug: gadopiclenol, Drug: Gadobutrol 1 MMOLE/ML Intravenous SolutionCross-over design: each patient receives gadopiclenol for the first MRI and then gadobutrol for the second MRI |
| gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI | Experimental | Drug: gadopiclenol, Drug: Gadobutrol 1 MMOLE/ML Intravenous SolutionCross-over design: each patient receives gadobutrol for the first MRI and then gadopiclenol for the second MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient presenting with known or suspected enhancing abnormality(ies) and/or lesion(s) in at least one body region based on a previous imaging procedure performed within 12 months prior to ICF signature. US patients are restricted to the breast in compliance with local approved indications of gadobutrol.
Key exclusion criteria (1 listed)
- Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m² assessed within 1 day prior to each contrast agent 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 |
|---|---|---|
| gadopiclenolSingle intravenous bolus injection | Drug | gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI, gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI |
| Gadobutrol 1 MMOLE/ML Intravenous SolutionSingle intravenous bolus injection | Drug | gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI, gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI |
Primary outcome
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI
Time frame: At first MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 1. At second MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 2, performed 2-14 days after gadobutrol-enhanced MRI.
The lesion visualization at patient level was based on 3 co-primary criteria on marching lesions: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor [internal morphology] or none [border delineation, contrast enhancement], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each co-criterion was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between Paired [unenhanced and contrast-enhanced] images and Pre-contrast [unenhanced] images was calculated for each of the 3 co-primary criteria and for each reader.
1 secondary outcome
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI
Time frame: At each of two MRI examinations with an interval of 2-14 days between two MRI examinations
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37462494Kuhl C, Csoszi T, Piskorski W, Miszalski T, Lee JM, Otto PM. Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI. Radiology. 2023 Jul;308(1):e222612. doi: 10.1148/radiol.222612.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing gadopiclenol and Gadobutrol 1 MMOLE/ML Intravenous Solution in people with Lesion in Body Region, run by Guerbet at 33 sites in 11 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Poland, South Korea, Germany, France and 6 more countries. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 27 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI (time frame: At first MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 1. At second MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 2, performed 2-14 days after gadobutrol-enhanced MRI.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03986138, which also lists 1 linked publication.
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 27 Oct 2025.