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

NCT06846853 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-28

No results posted yet for this study

Summary

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

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

Interventions

DRUG

Gadopiclenol

The enhanced images by Gadopiclenol and Gadobutrol will be compared.

DRUG

Gadobutrol (Gadavist, BAY86-4875)

Gadobutrol will be used as a comparator

Sponsors & Collaborators

  • UConn Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-25
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06846853 on ClinicalTrials.gov