Comparing two contrast agents for MRI of pituitary lesions

Gadopiclenol vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI: A Pilot Study

This study is testing a new contrast agent called Gadopiclenol against a standard one, Gadobutrol, to see if it can safely provide good images of pituitary lesions during MRI scans while using a lower dose.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: UConn Health (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Farmington, Connecticut)
• Trial ID: NCT06846853 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of Gadopiclenol, a new contrast agent, against Gadobutrol, a commonly used contrast agent, for visualizing pituitary lesions during MRI scans. It is a double-blinded pilot study, meaning neither the participants nor the researchers know which agent is being used, to eliminate bias in results. The study aims to determine if Gadopiclenol can provide comparable imaging quality at a lower dose, potentially reducing the risk of gadolinium toxicity. Participants will undergo two contrast-enhanced MRI examinations to assess the effectiveness of both agents.

Who should consider this trial

Good fit: Ideal candidates include adult males aged 18 and older or females aged 55 and older with known or suspected pituitary lesions.

Not a fit: Patients without suspected pituitary lesions or those who do not require a contrast-enhanced MRI examination will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer MRI procedures for patients with pituitary lesions by using a lower dose of gadolinium-based contrast agent.

How similar studies have performed: Previous studies have shown Gadopiclenol to be noninferior to Gadobutrol for other intracranial lesions, suggesting potential success for this approach.

Eligibility criteria

Inclusion criteria:

1. Male adult patient who is at 18 years old or above, or female adult patient who is at 55 years old or above.
2. 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.
3. 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.
4. 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.
5. Patient able and willing to participate in the trial.
6. 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.
7. Patient affiliated to national health insurance according to local regulatory requirements.

Exclusion criteria:

1. Patient presenting with known class III/IV congestive heart failure according to the New York Heart Association classification (NYHA).
2. 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.
3. Patient presenting with any contraindication to MRI examinations.
4. Patient previously randomized in this trial.
5. 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
6. 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.

8\. 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.

9\. 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).

12\. 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.

Where this trial is running

Farmington, Connecticut

• University of Connecticut Health Center — Farmington, Connecticut, United States (Recruiting)

Study contacts

• Study coordinator: Lihong Wang, MD, Ph D

Conditions Contrast Enhanced Images vs. Non-contrast Images; Gadopiclinol Enhanced Images vs. Gadobutrol Enhanced Images; Gadobutrol enhanced images; Gadopiclinol enhanced images