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NCT06846853 · ClinicalTrials.gov registry record · Phase 4
Gadopiclenol vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI (Magnetic Resonance Imaging)
A Phase 4 study of Contrast Enhanced Images vs. Non-contrast Images and Gadopiclinol Enhanced Images vs. Gadobutrol Enhanced Images, sponsored by UConn Health.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06846853: Recruiting Phase 4 study of Contrast Enhanced Images vs. Non-contrast Images and Gadopiclinol Enhanced Images vs. Gadobutrol Enhanced Images, sponsored by UConn Health.
NCT06846853 is a Phase 4 study of Contrast Enhanced Images vs. Non-contrast Images and Gadopiclinol Enhanced Images vs. Gadobutrol Enhanced Images that is actively recruiting participants, run by UConn Health. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06846853, a Phase 4 study of Contrast Enhanced Images vs. Non-contrast Images and Gadopiclinol Enhanced Images vs. Gadobutrol Enhanced Images, is actively recruiting participants, sponsored by UConn Health.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The primary outcome measures will include both subjective assessments and an objective measure. The subjective assessments will include part 1) the lesion intensity of the pituitary either having: a) Not Hypointense; b) Mildly Hypointense; c) Markedly Hypointense and part 2) the overall diagnostic quality of the contrast vs noncontrast and of the two contrast agent ( Godopiclinol vs. Godobutrol) side by side as: a) Prefer 1; b) No difference; c) Prefer 2. The objective measure is the Contrast/
Conditions Studied
Interventions
- DRUG Gadopiclenol
- DRUG Gadobutrol (Gadavist, BAY86-4875)
Study Locations (1)
Connecticut
- University of Connecticut Health Center - Farmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-03-01 |
| Est. Completion | 2025-12-25 |
| Phase | Phase 4 |
What NCT06846853 shows while recruiting
NCT06846853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Contrast Enhanced Images vs. Non-contrast Images appearing as the primary indexed condition, and to 2 interventions - of which Gadopiclenol is the first listed.
NCT06846853 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT06846853 about?
NCT06846853 is a clinical study titled "Gadopiclenol vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI (Magnetic Resonance Imaging)". 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 res...
What is the current status of trial NCT06846853?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2025-03-01. Estimated completion is 2025-12-25.
What conditions does trial NCT06846853 study?
This clinical trial studies the following conditions: Contrast Enhanced Images vs. Non-contrast Images, Gadopiclinol Enhanced Images vs. Gadobutrol Enhanced Images.
What interventions are being tested in trial NCT06846853?
The interventions under investigation include: Gadopiclenol (DRUG), Gadobutrol (Gadavist, BAY86-4875) (DRUG).
Who is sponsoring clinical trial NCT06846853?
This trial is sponsored by UConn Health, which has 178 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06846853 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06846853's enrollment target sits among peer trials
10 1941st of 2000 higher than 33 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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