Gadopiclenol

DRUG13 trials

Sponsors

Guerbet, Bracco Imaging S.p.A., Guerbet, Medical University of South Carolina, Columbia University, University of California, San Diego

Conditions

Blood Brain Barrier DefectBody IndicationCNS LesionCentral Nervous System DiseasesCongenital Heart DiseaseContrast Enhanced Images vs. Non-contrast ImagesGadopiclinol Enhanced Images vs. Gadobutrol Enhanced ImagesImage

Phase 1

Pharmacokinetics and Safety of Gadopiclenol in Japanese Healthy Volunteers

CompletedNCT04906005

GuerbetPharmacokinetics

Start: 2021-05-10End: 2021-07-27Updated: 2021-10-07

Phase 2

Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age

CompletedNCT05590884

GuerbetBody Indication, Central Nervous System Diseases, Pediatric Disorder

Start: 2022-09-21End: 2024-09-30Updated: 2025-10-28

Phase 3

Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)

CompletedNCT03986138

GuerbetLesion in Body Region

Start: 2019-08-27End: 2020-12-09Updated: 2025-10-27

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

CompletedNCT03996447

GuerbetBlood Brain Barrier Defect, CNS Lesion

Start: 2019-06-03End: 2020-09-11Updated: 2025-09-22

Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children

CompletedNCT06010173

GuerbetCNS Lesion, Lesion in Body Region

Start: 2023-07-21End: 2025-03-26Updated: 2025-05-20

Comparative Effectiveness of Gadopiclenol for Evaluation of Adult Congenital Heart Anatomy and Hemodynamics

Not yet recruitingNCT06406517

University of California, San DiegoCongenital Heart Disease

Start: 2024-05-31End: 2025-06-30Target: 160Updated: 2024-05-09

Evaluation of the Efficacy and Safety of Magnetic Resonance Angiography (MRA) Using Gadopiclenol Compared to Gadoterate Meglumine in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease

Not yet recruitingNCT07348640

GuerbetSteno-occlusive Disease

Start: 2026-02-02End: 2027-12-31Target: 315Updated: 2026-01-20

A Prospective, Multi-National, Randomized, Double-Blind, Crossover Study to Evaluate the Efficacy and Safety of Gadopiclenol-enhanced MRA Compared to Gadoterate Meglumine-enhanced MRA in the Assessment of Steno-occlusive Disease in Adult Patients with Suspected Vascular Disease

Not yet recruitingCTIS2024-518835-13-00

Guerbet, Bracco Imaging S.p.A.peripheral or abdominal/renal arteries, Suspected Vascular Disease of supra-aortic (carotid/vertebrobasilar)

Target: 40Updated: 2026-04-15

Phase 4

Gadopiclenol in Contrast Enhanced MRI of the Prostate

RecruitingNCT06226129

Columbia UniversityProstate Cancer

Start: 2024-02-14End: 2028-02-01Target: 150Updated: 2025-10-17

Gadopiclenol vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI (Magnetic Resonance Imaging)

RecruitingNCT06846853

UConn HealthContrast Enhanced Images vs. Non-contrast Images, Gadopiclinol Enhanced Images vs. Gadobutrol Enhanced Images

Start: 2025-03-25End: 2026-06-30Target: 10Updated: 2026-04-28

Randomized Comparison of Contrast Agents Gadopiclenol and Gadobutrol in the Workup of Incidental Renal and Adrenal Findings

RecruitingNCT07040865

Insel Gruppe AG, University Hospital BernSuspect Renal and Adrenal Imaging Findings

Start: 2025-08-18End: 2027-07-31Target: 104Updated: 2025-11-19

Unknown Phase

MRI Gadopiclenol Enhanced Imaging of CNS Tumors

WithdrawnNCT06127810

Medical University of South CarolinaImage

Start: 2024-12-30End: 2024-12-30Updated: 2025-02-04

Gadopiclenol vs Gadoxetate MRI for Liver Lesions

Enrolling by invitationNCT06596616

Icahn School of Medicine at Mount SinaiLiver Lesion

Start: 2024-07-01End: 2027-01-01Target: 23Updated: 2026-04-22

Related Papers

Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI

Radiology2023-07-0153 citations