Contrast-Enhanced MRI for Leptomeningeal Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if gadopiclenol, a new contrast agent used during MRI scans, can help detect early signs of leptomeningeal disease (LMD). LMD is a serious condition where cancer spreads to the membranes surrounding the brain and spinal cord. Participants will undergo specialized MRI scans to assess whether this contrast agent provides clearer images than standard methods. The trial seeks individuals with solid tumors who have had unclear MRI results for LMD and negative fluid tests from around the brain. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance early detection methods for LMD.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this MRI technique is safe for detecting leptomeningeal disease?
Studies have shown that both Gadavist and VUEWAY are safe as contrast agents in MRI scans. Researchers tested Gadavist in over 7,713 people, including children, and found it generally well tolerated. Only about 0.84% of patients reported side effects, mostly mild.
VUEWAY, also known as gadopiclenol, underwent safety evaluation in studies with over 1,083 patients, demonstrating a high level of safety. Ongoing monitoring after its release continues to confirm its safety, with no major health issues reported.
Both contrast agents assist doctors in visualizing the body during MRI scans, and research confirms their safety for this purpose.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a new MRI technique using gadopiclenol, a contrast agent that may offer clearer imaging for detecting leptomeningeal disease (LMD) in the brain. Unlike standard MRI contrast agents, gadopiclenol could provide enhanced visualization of the brain’s membranes, potentially leading to earlier and more accurate diagnosis of LMD. This could be a game-changer for patients, as early detection is crucial for managing this condition effectively. By improving the sensitivity and specificity of MRI scans, this approach might significantly impact treatment planning and outcomes for those affected by LMD.
What evidence suggests that this MRI technique is effective for detecting early LMD?
This trial will compare two contrast dyes for MRI scans: gadobutrol (Gadavist) and gadopiclenol (VUEWAY). Studies have shown that Gadavist effectively enhances MRI scans, allowing doctors to see lesions and blood flow in the brain and spine more clearly. Research indicates that it provides reliable diagnostic information for various conditions. In contrast, VUEWAY has demonstrated even better contrast at half the dose of Gadavist. Evidence suggests it improves the detection of brain and spine lesions, making it a promising option for early diagnosis of conditions like leptomeningeal disease. Both dyes are considered safe, supporting their use in MRI for clearer imaging results.15678
Who Is on the Research Team?
Rami Eldaya, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with a confirmed solid tumor and unclear or possible signs of leptomeningeal disease (LMD) on brain MRI, but no definite LMD found in spinal fluid tests. People with certain implants, pregnant individuals, those under 18, or clear evidence of LMD cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo brain MRI scans with gadopiclenol contrast to detect early LMD
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Gadavist
- VUEWAY
Trial Overview
The study compares two contrast agents—Gadavist and gadopiclenol (VUEWAY)—used during MRI scans to see which helps better detect early leptomeningeal disease in cancer patients.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Citations
Safety and Efficacy of Gadobutrol-Enhanced MRI in Patients ...
This study indicates that gadobutrol at a standard dose for MRI is safe in patients aged < 2 years and provides diagnostic information for multiple pathologies.
Contrast-Enhanced MRI for Leptomeningeal Disease
What is the purpose of this trial? To learn if gadopiclenol (a contrast agent) used during MRI scanning can help in the detection of early LMD.
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol ...
The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in ...
Gadobutrol: A Review in Contrast-Enhanced MRI and MRA
Gadobutrol represents an effective and safe diagnostic GBCA for use in CE MRI and MRA to visualize pathological lesions and vascular perfusion and flow-related ...
5.
journals.lww.com
journals.lww.com/investigativeradiology/fulltext/2024/05000/clinical_efficacy_of_gadobutrol__review_of_over_25.1.aspxClinical Efficacy of Gadobutrol: Review of Over 25 Years ...
Gadobutrol is an efficacious magnetic resonance imaging contrast agent for all age groups in various approved indications throughout the whole body.
GADAVIST (gadobutrol) injection, for intravenous use
The safety and effectiveness of GADAVIST have not been established with intrathecal use. GADAVIST is not approved for intrathecal use [see Dosage and ...
Off-label intrathecal use of gadobutrol: safety study and ...
This prospective study showed that intrathecal administration of gadobutrol in a dose of 0.5 mmol is safe. Non-serious adverse events were to a lesser degree ...
8.
researchgate.net
researchgate.net/publication/51175360_Safety_of_Gadobutrol_a_New_Generation_of_Contrast_Agents_Experience_From_Clinical_Trials_and_Postmarketing_SurveillanceSafety of Gadobutrol, a New Generation of Contrast Agents ...
Gadobutrol was well tolerated by adults, by children, by patients with impaired liver or kidney function, and by patients with cardiovascular disease. The ...
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