RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-01

Study Completion:2025-12-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06846853

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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). 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.

Inclusion Criteria

Exclusion 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.

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).
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.

Contacts and Locations

Study Contact

Stephen MacKinnon

CONTACT

860-679-8729

irb@uchc.edu

Leo Wolansky, MD

CONTACT

860-387-8252

wolansky@uchc.edu

Study Locations (Sites)

University of Connecticut Health Center

Farmington, Connecticut, 06030

United States

Collaborators and Investigators

Sponsor: UConn Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-01

Study Completion Date2025-12-25

Study Record Updates

Study Start Date2025-03-01

Study Completion Date2025-12-25

Terms related to this study

Keywords Provided by Researchers

Gadobutrol enhanced images
Gadopiclinol enhanced images

Additional Relevant MeSH Terms

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