ENROLLING_BY_INVITATION

Gadopiclenol vs Gadoxetate MRI for Liver Lesions

Conditions

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

The overall purpose of this study is to establish noninferiority of gadopiclenol MRI compared to gadoxetate MRI in terms of image quality and lesion detection/conspicuity in patients undergoing clinically indicated liver MRI in a prospective study. The research will be utilizing MRI; with enrollment goal of 75 subjects over the course of two years.

Official Title

MR Image Quality and Liver Lesion Detection With Gadopiclenol: Comparison With Gadoxetate Disodium

Quick Facts

Study Start:2024-07-01
Study Completion:2026-03-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ENROLLING_BY_INVITATION

Study ID

NCT06596616

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:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Acute renal insufficiency.
  2. * Severe chronic renal insufficiency (GFR \<30 mL/min/1.73 m2).
  3. * Age \<18y.
  4. * Unable or unwilling to give informed consent.
  5. * Contraindications for MRI (such as pacemakers, infusion pumps, pregnancy, allergy or previous adverse reactions to gadolinium contrast agents, severe claustrophobia).

Contacts and Locations

Principal Investigator

Sara Lewis, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

BMEII
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Sara Lewis, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

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 Date2024-07-01
Study Completion Date2026-03-27

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2026-03-27

Terms related to this study

Additional Relevant MeSH Terms

  • Liver Lesion