Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) (PICTURE)
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| ClinicalTrials.gov Identifier: NCT03996447 |
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Recruitment Status :
Completed
First Posted : June 24, 2019
Last Update Posted : July 2, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| CNS Lesion Blood Brain Barrier Defect | Drug: gadopiclenol Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial | Phase 3 |
The purpose of this trial is to evaluate a new gadolinium-based contrast agent (GBCA) gadopiclenol injection for Central Nervous System (CNS) lesion detection and visualization by conventional steady-state CNS imaging. .
This is a multi-center, international, prospective, double-blind, randomized, controlled,cross-over with comparator trial in male and female patients presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) who are scheduled to undergo a routine contrast-enhanced Magnetic Resonance Imaging (MRI) of the CNS.
This trial will be conducted in approximately 40 centers worldwide.
During the course of the trial, two MRIs will be obtained from each patient: one unenhanced and gadopiclenol-enhanced MRI; and one unenhanced and gadobutrol-enhanced MRI. MRI evaluations will be performed by on-site investigators and three independent off-site blinded readers.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 260 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Diagnostic |
| Official Title: | Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) |
| Actual Study Start Date : | June 3, 2019 |
| Actual Primary Completion Date : | September 11, 2020 |
| Actual Study Completion Date : | September 11, 2020 |
| Arm | Intervention/treatment |
|---|---|
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gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI
cross-over design. each patient will receive gadopiclenol for the first MRI and gadobutrol for the second MRI
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Drug: gadopiclenol
single intravenous (IV) bolus injection at a rate of 2ml/second Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial single intravenous (IV) bolus injection at a rate of 2ml/second |
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gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI
cross-over design. each patient will receive gadobutrol for the first MRI and gadopiclenol for the second MRI
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Drug: gadopiclenol
single intravenous (IV) bolus injection at a rate of 2ml/second Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial single intravenous (IV) bolus injection at a rate of 2ml/second |
- lesion visualization criteria for gadopiclenol-enhanced MRI compared to unenhanced MRI [ Time Frame: 1 day procedure ]The lesion visualization criteria is based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol by independent readers for the 3 most representative lesions.
- Lesion visualization criteria for gadopiclenol compared to gadobutrol [ Time Frame: 1 day procedure ]
the lesion visualization criteria is based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement assessed on the images acquired during the MRI performed with gadopiclenol and those performed with gadobutrol.
For each reader, only matching lesion between paired images of gadobutrol and gadopiclenol will be considered
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (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.
Exclusion Criteria:
- Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m² assessed within 1 day prior to each contrast agent injection
- Patient presenting extra cranial lesions and/or extra-dural lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996447
Show 33 study locations
| Principal Investigator: | Lorie Loevner, MD | University of Pennsylvania |
| Responsible Party: | Guerbet |
| ClinicalTrials.gov Identifier: | NCT03996447 |
| Other Study ID Numbers: |
GDX-44-010 |
| First Posted: | June 24, 2019 Key Record Dates |
| Last Update Posted: | July 2, 2021 |
| Last Verified: | May 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |