Actively Recruiting
Gadopiclenol vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI (Magnetic Resonance Imaging)
Led by UConn Health · Updated on 2026-04-28
10
Participants Needed
1
Research Sites
66 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the efficacy and safety of Gadopiclenol, an FDA-approved contrast agent, for visualizing pituitary lesions on MR images by comparing with the comparator, Gadobutrol, a clinically widely used contrast agent. The study is double-blinded, so neither the participants nor the researchers know which contrast agent is being used during each scan to avoid the bias of results.
CONDITIONS
Official Title
Gadopiclenol vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI (Magnetic Resonance Imaging)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 years or older, or female patients aged 55 years or older
- Known or strongly suspected pituitary lesion(s) with disrupted blood-brain barrier based on imaging within the last 12 months
- Scheduled for a contrast-enhanced MRI focused on the pituitary and agree to a second similar MRI for the trial
- If treated for a pituitary condition after previous imaging, still have a high suspicion of remaining lesion(s)
- Able and willing to participate in the trial
- Provided written informed consent prior to any trial procedures
- Affiliated with national health insurance as required locally
You will not qualify if you...
- Known class III/IV congestive heart failure (NYHA classification)
- Received investigational medicinal products within 7 days before trial or planned during trial
- Contraindications to MRI examinations
- Previously randomized in this trial
- Received any contrast agent (MRI or CT) within 3 days before first trial product or planned within 24 hours after second trial product
- Expected to have treatment or medical procedure affecting lesions between the two MRIs (stable corticosteroids or maintenance chemotherapy allowed)
- Medical, psychological, social, or geographical conditions compromising safety or participation
- Unlikely to comply with protocol or complete the trial
- Related to trial staff or investigators
- Acute or chronic renal insufficiency with eGFR below 30 mL/min/1.73 m²
- Known sensitivity or contraindication to study products or other gadolinium-based contrast agents
- Prisoners, pregnant women, or vulnerable populations excluded for protection
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Actively Recruiting
Research Team
L
Lihong Wang, MD, Ph D
CONTACT
L
Leo Wolansky, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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