PICTURE: Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

• Sponsor: Guerbet (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03996447
• Collaborator: (none)
• Enrollment: 260
• Locations: 33
• Arms: 2
• Actual Duration (Months): 15.3
• Patients Per Site: 7.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

the trial aims to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Condition or Disease	Intervention/Treatment	Phase
CNS Lesion; Blood Brain Barrier Defect	Drug: gadopiclenol; Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial	Phase 3

Detailed Description

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 Design

• Study Type: Interventional
• 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: Jun 3, 2019
• Actual Primary Completion Date: Sep 11, 2020
• Actual Study Completion Date: Sep 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: 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	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
Other: 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	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

Outcome Measures

Primary Outcome Measures

1. lesion visualization criteria for gadopiclenol-enhanced MRI compared to unenhanced MRI [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.

2. Lesion visualization criteria for gadopiclenol compared to gadobutrol [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ASCLEPES Research Centers	Panorama City	California	United States	91402
2	University of Connecticut Health Center	Farmington	Connecticut	United States	06030
3	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
4	Northwest Neurology, Ltd.	Rolling Meadows	Illinois	United States	600008
5	University of Missouri Hospital and Clinic	Columbia	Missouri	United States	65212
6	University Of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
7	South Carolina Clinical & Translational Research (SCTR) Institute	Charleston	South Carolina	United States	29425
8	University Of Washington - Medical Center	Seattle	Washington	United States	98195
9	ZNA Middelheim	Antwerp		Belgium
10	UZ Brussel - Campus Jette	Brussel		Belgium	1090
11	CHRU - Hôpital Roger Salengro - Neurologie	Lille		France
12	Centre Hospitalier Sainte-Anne	Paris		France	75014
13	CHU La Miletrie	Poitiers		France
14	CHRU Strasbourg Hôpital de Hautepierre	Strasbourg		France	67098
15	Uniklinik Mannheim	Mannheim		Germany	68167
16	Semmelweis Egyetem - Neurology	Budapest		Hungary	1083
17	Orszagos Klinikai Idegtudomanyi Intezet	Budapest		Hungary	1145
18	Debreceni Egyetem Klinikai Kozpont	Debrecen		Hungary
19	Pecsi Tudomanyegyetem Klinikai Kozpont - Idegsebeszeti Klinika	Pécs		Hungary	Pécs
20	Szegedi Tudomanyegyetem AOK	Szeged		Hungary	6725
21	ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila, Ospedale Regionale San Salvatore	L'Aquila		Italy
22	Fondazione I.R.C.C.S. C.Mondino	Pavia		Italy	27100
23	Istituto Neurologico Mediterraneo-Neuromed, I.R.C.C.S.	Pozzilli		Italy	86077
24	Azienda Sanitaria Universitaria Integrata di Trieste-PO Cattinara	Trieste		Italy	34149
25	Konkuk University Medical Center	Seoul		Korea, Republic of	05030
26	Asan Medical Center	Seoul		Korea, Republic of	5505
27	Axis Heilsa S. de R.L. de C.V. (Althian)	Monterrey		Mexico	64060
28	Clinical Research Institute S.C	Tlalnepantla de Baz		Mexico	54055
29	Uniwersyteckie Centrum Kliniczne w Gdańsku, Zakład Radiologii	Gdańsk		Poland	80-214
30	Hospital del Mar	Barcelona		Spain	08003
31	M.D. Anderson Cancer Center Madrid	Madrid		Spain	28033
32	Hospital Clínico San Carlos	Madrid		Spain	28040
33	Taipei Veterans General Hospital	Taipei		Taiwan	11217

Sponsors and Collaborators

• Guerbet

Investigators

• Principal Investigator: Lorie Loevner, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guerbet
• ClinicalTrials.gov Identifier: NCT03996447
• Other Study ID Numbers: GDX-44-010
• First Posted: Jun 24, 2019
• Last Update Posted: Jul 2, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 2, 2021