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

NCT06846853 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 25-175-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Gadobutrol enhanced images; Gadopiclinol enhanced images

Outcome Measures

Primary Outcomes (1)

• hypointense for lesions with respect to pituitary

  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

  Two MRI scans will be conducted separated by 3-14 days.

Study Arms (2)

Gadopiclinol (brand name, Elucirem) first group

EXPERIMENTAL

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

Drug: Gadopiclenol

Gadobutrol (Brand name, Gadavist) first group

ACTIVE COMPARATOR

Participants of Arm 2 will use Gadobutrol contrast for the MRI scan and Gadopiclinol contrast for the second MRI scan.

Drug: Gadobutrol (Gadavist, BAY86-4875)

Interventions

Gadopiclenol DRUG

The enhanced images by Gadopiclenol and Gadobutrol will be compared.

Gadopiclinol (brand name, Elucirem) first group

Gadobutrol (Gadavist, BAY86-4875) DRUG

Gadobutrol will be used as a comparator

Gadobutrol (Brand name, Gadavist) first group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male adult patient who is at 18 years old or above, or female adult patient who is at 55 years old or above.
• Patient presenting with known or highly suspected pituitary lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) based on results of a previous imaging procedure such as Computed Tomography (CT) or MRI, which should have been performed within 12 months prior to informed consent form signature.
• Patient scheduled for a contrast-enhanced MRI examination with a focus on pituitary for clinical reasons and agreeing to have a second contrast-enhanced MRI examination for the purpose of the trial.
• If the patient was treated (either with radiation, surgery, biopsy or other relevant treatments) for a pituitary condition between previous imaging evaluation and trial MRI, there should still be a high suspicion of remaining lesion(s) on the basis of available clinical information.
• Patient able and willing to participate in the trial.
• Patient having read the information and having provided his/her consent to participate in writing by dating and signing the informed consent prior to any trial related procedure being conducted.
• Patient affiliated to national health insurance according to local regulatory requirements.

You may not qualify if:

• Patient presenting with known class III/IV congestive heart failure according to the New York Heart Association classification (NYHA).
• Patient having received any investigational medicinal product within 7 days prior to trial entry or scheduled to receive any investigational treatment in the course of the trial.
• Patient presenting with any contraindication to MRI examinations.
• Patient previously randomized in this trial.
• Patient having received any contrast agent (MRI or CT) within 3 days prior to first trial product administration, or scheduled to receive any contrast agent during the course of the trial or within 24 hours after the second trial product administration
• Patient expected/scheduled to have any treatment or medical procedure (e.g. chemotherapy, radiotherapy, biopsy or surgery etc.) that may impact the aspects of the imaged lesions between the 2 MRI examinations. (Patients under corticosteroids and/or maintenance chemotherapy with a stable dose at the time of screening visit and throughout the trial can be included).
• Patient with anticipated, current or past condition (medical, psychological, social or geographical) that would compromise the patient's safety or her/his ability to participate in the trial.
• \. Patient unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits and/or unlikelihood of completing the trial.
• \. Patient related to the investigator or any other trial staff or relative directly involved in the trial conduct. 10. Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m² assessed within 1 day prior to each contrast agent injection. 11. Patient with known contra-indication(s) to the use or with known sensitivity to one of the products under investigation or to other GBCAs (such as hypersensitivity, post contrast acute kidney injury).
• \. Patient who are prisoners, pregnant women, or educationally disadvantaged persons known as vulnerable population will be excluded as well to protect the rights and welfare of these participants.

Sponsors & Collaborators

• UConn Health: lead

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

RECRUITING

Related Links

• This study aimed to demonstrate that contrast-enhanced MRI of the central nervous system (CNS) with gadopiclenol at 0.05 mmol/kg is not inferior to gadobutrol at 0.1 mmol/kg, and superior to unenhanced MRI. The results supported the hypothesis.

MeSH Terms

Interventions

gadopiclenol; gadobutrol

Central Study Contacts

Lihong Wang, MD, Ph D

CONTACT

860-679-7881; lwang@uchc.edu

Leo Wolansky, MD

CONTACT

860-387-8252; wolansky@uchc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a double-blinded cross-over study. Study participants will be assigned randomly to have either Gadopiclenol or Gadobutrol contrast for the first MRI scan and followed by the other contract for the second MRI scan 3-14 days later.

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 26, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 28, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)