Status:
WITHDRAWN
MRI Gadopiclenol Enhanced Imaging of CNS Tumors
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Guerbet
Conditions:
Image
Eligibility:
All Genders
18+ years
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 G...
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 partic...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Female or male adult patient (18 years and older).
- 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).
- Patient scheduled for a routine CNS contrast-enhanced MRI examination for clinical reasons.
- Patient able and willing to participate in the study.
- Patient with health insurance.
- Exclusion Criteria
- 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.
- 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).
- Patient with any contraindication to MRI examinations including active implants, passive implants which are MRI incompatible, and metallic foreign bodies.
- Patient with known contra-indication(s) to the use or with known sensitivity to any GBCA.
- Patient having received any contrast agent (MRI or CT) within 3 days prior to study gadopiclenol administration
Exclusion
Key Trial Info
Start Date :
December 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06127810
Start Date
December 30 2024
End Date
December 30 2024
Last Update
February 4 2025
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