Evaluation of Gadopiclenol for central nervous system magnetic resonance imaging

Phase 1

• Conditions: Patient presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (e.g., primary and secondary tumors); MedDRA version: 20.1Level: LLTClassification code 10056941Term: MRI brainSystem Organ Class: 100000004848; MedDRA version: 20.1Level: LLTClassification code 10056922Term: MRI brain abnormalSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-003988-54-HU
• Lead Sponsor: Guerbet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-25
• Last Update Posted: 6 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

- Female or male adult patient (patient having reached legal majority age).
- Patient presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (e.g., primary and secondary tumors) based on results of a previous imaging procedure such as Computed Tomography (CT) or MRI, which should have been performed within 12 months prior to ICF signature.
- Patient scheduled for a CNS contrast-enhanced MRI examination for clinical reasons and agreeing to have a second contrast-enhanced MRI examination for the purpose of the trial.
- Patient having read the information and having provided his/her consent to participate in writing by dating and signing the informed consent prior to any trial related procedure being conducted.

Some other inclusion criteria are listed in the trial protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

- Patient presenting extra cranial lesions and/or extra-dural lesions.
- Patient presenting with an acute relapse of multiple sclerosis as qualifying CNS lesion.
- Patient presenting with any contraindication to MRI examinations.
- Patient previously randomized in this trial.
- Patient having received any contrast agent (MRI or CT) within 3 days prior to first trial product administration, or scheduled to receive any contrast agent during the course of the trial or within 24 hours after the second trial product administration.

Some other exclusion criteria are listed in the trial protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified