MRI Gadopiclenol Enhanced Imaging of CNS Tumors

NCT06127810 | Withdrawn FDA Drug FDA Device

• 1 other identifier: Pro00129735
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Image

Keywords

MRI; Radiology

Outcome Measures

Primary Outcomes (1)

• Visibility of lesions

  Visibility of lesions and diagnostic capabilities of 0.068T MRI

  1 Day

Study Arms (2)

3T Contrast Enhanced Images First

Device: CE MRI on 0.064T Scanner; Drug: Gadopiclenol

0.064 Contrast Enhanced Images First

Device: CE MRI on 0.064T Scanner; Drug: Gadopiclenol

Interventions

CE MRI on 0.064T Scanner DEVICE

Pt will undergo contrast enhanced images using Gadopiclenol on Hyperfine MRI

0.064 Contrast Enhanced Images First; 3T Contrast Enhanced Images First

Gadopiclenol DRUG

Subjects will receive Gadopiclenol instead of standard of care contrast

0.064 Contrast Enhanced Images First; 3T Contrast Enhanced Images First

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Female or male adult patient (18 years and older).
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Guerbet: collaborator

MeSH Terms

Interventions

gadopiclenol

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 13, 2023
• Study Start: December 30, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-01