Leptomeningeal DiseaseNCT07415018
Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease
A study testing MRI Scan, VUEWAY and Gadavist in people with Leptomeningeal Disease, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if gadopiclenol (a contrast agent) used during MRI scanning can help in the detection of early LMD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leptomeningeal Disease
- What is being tested?
- MRI Scan, VUEWAY and Gadavist
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2026to 31 Jul 2029
- Phase
- Interventional
- 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
- Patients with tissue confirmed solid malignancy and standard of care brain MRI with equivocal results for LMD (questionable or possible) and negative LP CSF sampling or patients with high risk clinical LMD and negative brain MR and LP CSF sampling. Initially, we will target solid tumors, but if more patients are needed to meet the study power we will enroll liquid tumors.
- Participants > 18 years of age.
- Participants are able to consent.
Who cannot join
- Participants with CSF sampling positive for LMD or MR brain/spine with definitive evidence of LMD.
- Participants with implantable devices that can not be scanned with MR safe mode for participant safety.
- Pregnant participants or potentially pregnant participants are at risk of contrast on the fetus
- Pediatric participants < 18 years of age.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Rami Eldaya, MD, 713-745-2945, reldaya@mdanderson.org
Rami Eldaya, MD
About this study
To learn if gadopiclenol (a contrast agent) used during MRI scanning can help in the detection of early LMD.
Read the detailed description
- Primary Objectives Primary Aim: Establish the ability of VUEWAY® (gadopiclenol) to detect early CNS LMD in brain MR while optimizing the ideal scan parameters including dose, sequences, and optimal timing for detection of CNS LMD in brain MRI. Brain MR offers a noninvasive alternative/complementary method to CNS sampling for detection of LMD. However, sensitivity for disease detection remains acceptable at best ranging from 33% in hematological malignancies in some studies to 75% (7, 8). This limits detection of early LMD thus potentially delaying diagnosis and initiation of life-saving treatment. We hypothesize that the excellent relaxivity of VUEWAY® (gadopiclenol) coupled with its safety profile including lower dosage compared to other contrast agents can be utilized to optimize an LMD specific MR brain protocol to improve MR ability to detect early LMD disease.
- Secondary Objectives Secondary Aim: Establish the ideal protocol and dose of VUEWAY® (gadopiclenol) for the detection of parenchymal brain metastatic disease. Brain MRI is the primary modality for detection and screening of intracranial metastasis. Brain MRI detects metastasis in 70% of participants that are asymptomatic at the time of diagnosis (9). However, sensitivity of MR for detection of smaller metastasis depends on acquisition sequences, dose of contrast, and timing of scanning after contrast administration (10-12). We hypothesize that the excellent relaxivity of VUEWAY® (gadopiclenol) coupled with its safety profile including lower dosage compared to other contrast agents can be utilized to increase detection of smaller parenchymal metastatic lesions on brain MR exams. Furthermore, in addition to serving as aim 2 for this study, this will serve as an internal control for quality assessment for aim 1.
- Conditions
- Leptomeningeal Disease
- Being tested
- MRI Scan, VUEWAY, Gadavist
- Medical subject headings
- Meningeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI ScanProcedure or surgery
Given during standard of care
VUEWAYDrug
Also called gadopiclenol
Given by IV
GadavistDrug
Also called gadobutrol
Given by IV
| Study group | Role | What they receive |
|---|---|---|
| MRI Scan with Gadavist (gadobutrol) / VUEWAY (gadopiclenol) | Other | Participants found to be eligible to take part in this study and agree to take part, will have brain MRI scans as part of standard of care. Then, within a week (preferably within 48 hours) of the participants routine brain MRI scans, you will have LMD-focused brain MRI scans with gadopiclenol contrast. Specifically, MRI scans will be done immediately after a small amount of gadopiclenol is given through an IV catheter placed into a vein, and then at 10 and 30 minutes thereafter. Then, a second dose of gadopiclenol will be given, and MRI scans will be done immediately after. The MRI scans performed for research purposes will take approximately 50 minutes to complete. You will be followed by routing clinical and imaging guidelines for 6 months or until the confirmation of LMD (whichever comes first). Receives: Procedure: MRI Scan; Drug: VUEWAY; Drug: Gadavist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start10 Jun 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leptomeningeal DiseaseStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rami Eldaya, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415018
- Sponsor's protocol ID
- 2025-1395
- Other IDs
- NCI-2026-00997
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease
- ClinicalTrials.gov ID
- NCT07415018
- Acronym / sponsor ID
- 2025-1395
- Conditions
- Leptomeningeal Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 17 Feb 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.
To learn if gadopiclenol (a contrast agent) used during MRI scanning can help in the detection of early LMD.
Detailed description
- Primary Objectives Primary Aim: Establish the ability of VUEWAY® (gadopiclenol) to detect early CNS LMD in brain MR while optimizing the ideal scan parameters including dose, sequences, and optimal timing for detection of CNS LMD in brain MRI. Brain MR offers a noninvasive alternative/complementary method to CNS sampling for detection of LMD. However, sensitivity for disease detection remains acceptable at best ranging from 33% in hematological malignancies in some studies to 75% (7, 8). This limits detection of early LMD thus potentially delaying diagnosis and initiation of life-saving treatment. We hypothesize that the excellent relaxivity of VUEWAY® (gadopiclenol) coupled with its safety profile including lower dosage compared to other contrast agents can be utilized to optimize an LMD specific MR brain protocol to improve MR ability to detect early LMD disease.
- Secondary Objectives Secondary Aim: Establish the ideal protocol and dose of VUEWAY® (gadopiclenol) for the detection of parenchymal brain metastatic disease. Brain MRI is the primary modality for detection and screening of intracranial metastasis. Brain MRI detects metastasis in 70% of participants that are asymptomatic at the time of diagnosis (9). However, sensitivity of MR for detection of smaller metastasis depends on acquisition sequences, dose of contrast, and timing of scanning after contrast administration (10-12). We hypothesize that the excellent relaxivity of VUEWAY® (gadopiclenol) coupled with its safety profile including lower dosage compared to other contrast agents can be utilized to increase detection of smaller parenchymal metastatic lesions on brain MR exams. Furthermore, in addition to serving as aim 2 for this study, this will serve as an internal control for quality assessment for aim 1.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI Scan with Gadavist (gadobutrol) / VUEWAY (gadopiclenol) | Other | Procedure: MRI Scan, Drug: VUEWAY, Drug: GadavistParticipants found to be eligible to take part in this study and agree to take part, will have brain MRI scans as part of standard of care. Then, within a week (preferably within 48 hours) of the participants routine brain MRI scans, you will have LMD-focused brain MRI scans with gadopiclenol contrast. Specifically, MRI scans will be done immediately after a small amount of gadopiclenol is given through an IV catheter placed into a vein, and then at 10 and 30 minutes thereafter. Then, a second dose of gadopiclenol will be given, and MRI scans will be done immediately after. The MRI scans performed for research purposes will take approximately 50 minutes to complete. You will be followed by routing clinical and imaging guidelines for 6 months or until the confirmation of LMD (whichever comes first). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with tissue confirmed solid malignancy and standard of care brain MRI with equivocal results for LMD (questionable or possible) and negative LP CSF sampling or patients with high risk clinical LMD and negative brain MR and LP CSF sampling. Initially, we will target solid tumors, but if more patients are needed to meet the study power we will enroll liquid tumors.
- Participants > 18 years of age.
- Participants are able to consent.
Key exclusion criteria (4 listed)
- Participants with CSF sampling positive for LMD or MR brain/spine with definitive evidence of LMD.
- Participants with implantable devices that can not be scanned with MR safe mode for participant safety.
- Pregnant participants or potentially pregnant participants are at risk of contrast on the fetus
- Pediatric participants < 18 years of age.
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 |
|---|---|---|
| MRI ScanGiven during standard of care | Procedure or surgery | MRI Scan with Gadavist (gadobutrol) / VUEWAY (gadopiclenol) |
| VUEWAYAlso: gadopiclenolGiven by IV | Drug | MRI Scan with Gadavist (gadobutrol) / VUEWAY (gadopiclenol) |
| GadavistAlso: gadobutrolGiven by IV | Drug | MRI Scan with Gadavist (gadobutrol) / VUEWAY (gadopiclenol) |
Primary outcome
Safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 18 Jun 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Leptomeningeal Disease
RecruitingPhase 1/2
Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases
Leptomeningeal Metastasis
Active, not recruitingObservational study
SERS-Based Diagnosis of Leptomeningeal Metastasis in EGFR-Mutant NSCLC
Lung Adenocarcinoma EGFR-mutated, Leptomeningeal Metastasis From Lung Cancer
Recruiting
Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
RecruitingPhase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
Metastatic Breast Cancer, Leptomeningeal Disease
RecruitingPhase 1/2
Phase I/II Study of Intrathecal/Ommaya T-DXd in HER2-Expressing Breast Cancer With Leptomeningeal/Brain Metastases
Breast Cancer
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.
Rami Eldaya, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI Scan, VUEWAY and Gadavist in people with Leptomeningeal Disease, run by M.D. Anderson Cancer Center at 1 site in United States.
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 3 inclusion and 4 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 18 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 1 site in United States. 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.
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 Rami Eldaya, MD ((713) 745-2945, reldaya@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year.). 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 18 Jun 2026.