MRI Gadopiclenol Enhanced Imaging of CNS Tumors

A Pilot Study of Gadopiclenol for Imaging Central Nervous System (CNS) Tumors at Point of Care Magnetic Resonance Imaging (MRI)

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

Study Overview

• Status: Withdrawn
• Conditions: Image
• Intervention / Treatment: Device: CE MRI on 0.064T Scanner; Drug: Gadopiclenol

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 Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visibility of lesions	Visibility of lesions and diagnostic capabilities of 0.068T MRI	1 Day

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Guerbet

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: MRI; Radiology
• Other Study ID Numbers: Pro00129735

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes