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

Conditions

• Contrast Enhanced Images vs. Non-contrast Images
• Gadopiclinol Enhanced Images vs. Gadobutrol Enhanced Images

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Gadopiclenol — DRUG
  The enhanced images by Gadopiclenol and Gadobutrol will be compared.
• Gadobutrol (Gadavist, BAY86-4875) — DRUG
  Gadobutrol will be used as a comparator

Study Details

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.

Key Dates

Start date

Mar 25, 2025

Status verified

Apr 2025

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

10 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Gadopiclinol (brand name, Elucirem) first group
  Participants of Arm 1 will use Gadopiclinol (Brand name, Elucirem) contrast for the first MRI scan and use Gadobutrol (Brand name, Gadavist)contrast for the second MRI scan
• Active Comparator: Gadobutrol (Brand name, Gadavist) first group
  Participants of Arm 2 will use Gadobutrol contrast for the MRI scan and Gadopiclinol contrast for the second MRI scan.

Primary Outcome Measure

hypointense for lesions with respect to pituitary [ Time Frame: Two MRI scans will be conducted separated by 3-14 days. ]

Central Contacts

• Lihong Wang, MD, Ph D
  860-679-7881
  [email protected]
• Leo Wolansky, MD
  860-387-8252
  [email protected]

Locations (1)

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