MRI Gadopiclenol Enhanced Imaging of CNS Tumors
Study Details
Study Description
Brief Summary
The purpose of this pilot study is to compare a standard of care MRI scan to a non-standard of care MR imaging with portable (0.064 Tesla) MRI following the administration of non-SOC contrast called Gadopiclenol on 10 subjects with known brain tumors.
Participants will be randomized to receive either standard MRI or portable MRI first following contrast injection
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This study compares a routine MRI scan with a new portable MRI scanner known as the "Hyperfine" using a contrast dye called Gadopiclenol, the contrast is FDA approved. If participants choose to participate in this study, they will receive two MRI scans on the same day. One on the traditional standard of care MRI scanner and the other on the new portable Hyperfine MRI. The Hyperfine MRI scanner is not FDA approved due to being a very low risk medical device. However, the device is compliant with all of the FDA requirements regarding design control regulations and risk analysis. Participants will only receive one contrast injection that will be used for both scans. The selection of which scan is given first will be randomly selected (50/50 chance). Participation in this study will last two days. The first day participants will receive both MRI scans and the second day participants will receive a phone call from the research staff to check on them.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 3T Contrast Enhanced Images First
|
Device: CE MRI on 0.064T Scanner
Pt will undergo contrast enhanced images using Gadopiclenol on Hyperfine MRI
Drug: Gadopiclenol
Subjects will receive Gadopiclenol instead of standard of care contrast
|
| 0.064 Contrast Enhanced Images First
|
Device: CE MRI on 0.064T Scanner
Pt will undergo contrast enhanced images using Gadopiclenol on Hyperfine MRI
Drug: Gadopiclenol
Subjects will receive Gadopiclenol instead of standard of care contrast
|
Outcome Measures
Primary Outcome Measures
- Visibility of lesions [1 Day]
Visibility of lesions and diagnostic capabilities of 0.068T MRI
Eligibility Criteria
Criteria
Inclusion Criteria
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Female or male adult patient (18 years and older).
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Patient presenting, at the time of inclusion, with known or highly suspected focal areas of disrupted Blood Brain Barrier (BBB) due to primary or secondary tumor/s. This lesion must have been detected on a previous imaging procedure (computerized Tomography (CT) or MRI).
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Patient scheduled for a routine CNS contrast-enhanced MRI examination for clinical reasons.
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Patient able and willing to participate in the study.
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Patient with health insurance.
Exclusion Criteria
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Patient presenting with acute or chronic Grade III (at least) renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m² based on eGFR assessment on the day of each MRI.
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Pregnant or breast-feeding female patient (a female patient of childbearing potential must be using a medically approved contraception method until the last study visit).
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Patient with any contraindication to MRI examinations including active implants, passive implants which are MRI incompatible, and metallic foreign bodies.
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Patient with known contra-indication(s) to the use or with known sensitivity to any GBCA.
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Patient having received any contrast agent (MRI or CT) within 3 days prior to study gadopiclenol administration
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Medical University of South Carolina
- Guerbet
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00129735