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

Phase 4

Recruiting

• Conditions: Contrast Enhanced Images vs. Non-contrast Images; Gadopiclinol Enhanced Images vs. Gadobutrol Enhanced Images
• Interventions: Drug: Gadopiclenol; Drug: Gadobutrol (Gadavist, BAY86-4875)

• Registration Number: NCT06846853
• Lead Sponsor: UConn Health

Brief 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.

Detailed Description

Gadopiclenol (brand name Elucirem), initially invented by Guerbet, is an FDA-approved macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity and high kinetic stability. The higher relaxivity allows for a lower dose of gadopiclenol, reducing the total amount of gadolinium administration (hence reducing the toxicity of gadolinium) while preserving imaging quality.

Gadopiclenol was approved by the FDA with a recommended dose of 0.05 mmol/kg for adults and pediatric patients aged 2 years and older. The PICTURE Trial demonstrated that Gadopiclenol at 0.05 mmol/kg which is half dose of standard macrocyclic GBCAs (Gadobutrol at 0.1 mmol/kg) revealed noninferiority for contrast-enhancing intracranial lesions against the background of nonenhancing brain.

A pituitary microadenoma or a Rathke's cyst is typically demonstrated on MRI by virtue of hypoenhancement of the lesion against the background of the hyperenhancing pituitary. Dynamic pituitary imaging with Gadopiclenol has not been investigated so far.

This pilot study will assess the value of Gadopiclenol at 0.05 mmol/kg vs. Gadobutrol 0.1 mmol/kg as a contrast agent for MRI in the evaluation of pituitary lesions. We hypothesize that there will be a trend that Gadopiclenol will increase the enhancement of the background pituitary gland to a similar degree. The safety data utilizing Gadopiclenol will also be evaluated. We anticipate comparable safety of 0.05 mmol/kg of Gadopiclenol and 0.1 mmol/kg Gadobutrol.

Study Timeline

• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-20
• Study First Posted: 2025-02-26
• Study Start: 2025-03-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-09-23
• Study Completion: 2025-12-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Gadopiclinol (brand name, Elucirem) first group	Gadopiclenol	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
Gadobutrol (Brand name, Gadavist) first group	Gadobutrol (Gadavist, BAY86-4875)	Participants of Arm 2 will use Gadobutrol contrast for the MRI scan and Gadopiclinol contrast for the second MRI scan.

Primary Outcome Measures

Name	Time	Method
hypointense for lesions with respect to pituitary	Two MRI scans will be conducted separated by 3-14 days.	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/Noise intensity of the pituitary: \[Signal Intensity Background Pituitary - Signal Intensity Lesion\] / Signal Intensity Air

Trial Locations

Locations (1)

University of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States