Gadolinium-Based Contrast Agents for Brain Tumor Imaging
(Contrast PMR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how well a special dye called gadolinium, already approved by the FDA, helps doctors detect brain tumors using a portable MRI machine. The goal is to determine if the dye enhances the visibility of brain lesions (damaged areas) that disrupt the blood-brain barrier, the brain's protective shield. This study targets individuals who have, or are suspected to have, brain lesions affecting the blood-brain barrier, as shown in a recent MRI scan. Participants will undergo two MRI scans: one before and one after receiving the gadolinium injection. As an unphased trial, this study allows participants to contribute to innovative research that could improve brain tumor detection.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that gadolinium-based contrast agents are safe for brain tumor imaging?
Research has shown that gadolinium-based contrast agents (GBCAs) are generally safe for MRI scans. Used in over 300 million scans worldwide for more than 35 years, most people tolerate them well. However, concerns exist about these agents possibly leaving deposits in the brain after repeated use. The FDA is investigating this to understand any potential risks. Despite these concerns, GBCAs remain commonly used to enhance MRI images, especially when doctors need a clearer view of brain lesions.12345
Why are researchers excited about this trial?
Researchers are excited about gadolinium-based contrast agents (GBCAs) for brain tumor imaging because they offer enhanced visibility of lesions when used with the Swoop® Portable MR Imaging® System. Unlike traditional MRI systems, this portable setup allows for imaging in diverse settings, such as at the bedside or in outpatient clinics, making it more accessible. GBCAs improve the clarity of MRI scans by highlighting differences between normal and abnormal tissues, which can be crucial for accurate diagnosis and treatment planning. This trial aims to demonstrate the effectiveness of GBCAs in enhancing image quality, potentially leading to better patient outcomes with more convenient and timely imaging options.
What evidence suggests that gadolinium-based contrast agents are effective for brain tumor imaging?
Studies have shown that gadolinium-based contrast agents (GBCAs) enhance MRI (Magnetic Resonance Imaging) scans by highlighting brain tumors. This enhancement helps doctors distinguish between cancerous and non-cancerous tumors by revealing areas where tumors affect the brain's protective barrier. Consequently, the tumor's size and shape become easier to see. Hospitals commonly use GBCAs because they provide detailed images that aid in diagnosis. Research also supports their ability to improve tumor images, which assists in planning effective treatment. In this trial, participants will undergo portable MRI scans both before and after GBCA administration to assess the added value of contrast enhancement.56789
Are You a Good Fit for This Trial?
Adults with known or suspected brain lesions that may disrupt the blood-brain barrier can join this study. They'll have a portable MRI scan, get an injection of a contrast agent, and then another scan. The trial is at least in three places for diverse participants.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-contrast Imaging
Participants undergo a pre-contrast portable MRI scan
Contrast Administration and Post-contrast Imaging
Participants receive an intravenous GBCA injection followed by a post-contrast portable MRI scan
Follow-up
Participants are monitored for safety and effectiveness after imaging
What Are the Treatments Tested in This Trial?
Interventions
- Gadolinium Based Contrast Agents (GBCA)
Trial Overview
The trial tests if FDA-approved gadolinium-based contrast agents help see brain lesions better on portable MRIs. Participants will be scanned before and after getting the contrast to compare lesion visibility by expert neuroradiologists.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
This prospective, interventional, single-arm study will collect data from patients in the hospital and/or outpatient setting undergoing portable magnetic resonance imaging (pMRI) using the Swoop® Portable MR Imaging® System (0.064 T). Each participant will undergo a pre-contrast portable MRI (pMRI) imaging scan, followed by intravenous administration of an FDA approved gadolinium-based contrast agent (GBCA), and then complete a post-contrast pMRI imaging scan. The study will assess lesion visibility between pre- and postcontrast images to assess the added value of contrast enhancement.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hyperfine
Lead Sponsor
Citations
Gadolinium-Based Contrast Agents for MR Cancer Imaging
Gadolinium based contrast agents are the most commonly used contrast agents in clinical MRI. There have been significant efforts to design and develop novel Gd( ...
Gadolinium‐Based Contrast Agents (GBCAs) for MRI: A ...
Providing an example, GBCAs can help distinguish malignant from benign brain tumors, since they can provide insights into the degree of tumor ...
Gadolinium contrast agents- challenges and opportunities ...
As a result, the pH-responsive capability and the use of contrast agents provide better MR imaging of tumors [4]. According to several studies, contrast agents ...
The Application, Safety, and Recent Developments of ...
The use of gadolinium-based contrast agents (GBCA) in MRI has been associated with adverse effects, including free gadolinium deposition ...
Gadolinium Magnetic Resonance Imaging - StatPearls - NCBI
Gadolinium-based MRI contrast agents aid physicians in diagnosing and treating a variety of pathological processes by improving the visualization of specific ...
Evaluation of Gadolinium Based Contrast Agents for ...
The intent of the study is to demonstrate the established benefits of gadolinium-based contrast agents are observable in T1W images at 64 mT.
Gadolinium-Based Contrast Agent Use, Their Safety, and ...
Use of gadolinium-based contrast agents (GBCAs) for MRI enhancement is useful in some instances and has been considered safe in most cases.
FDA evaluating the risk of brain deposits with repeated use ...
FDA evaluating the risk of brain deposits with repeated use of gadolinium-based contrast agents for magnetic resonance imaging.
Gadolinium Contrast: Clear Safety Information and When ...
Gadolinium contrast agents have been used safely in more than 300 million MRI scans over 35 years – but knowing the real risks versus the ...
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