Comparison of Contrast Agents in Liver Magnetic Resonance (MR) for the Detection of Hepatic Metastases

NCT04973007 | Terminated Phase 4 DMC FDA Drug

• 2 other identifiers: 19-1045.ccP30CA046934
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

If an abbreviated hepatobiliary phase (HBP) protocol liver MR with gadobenate dimeglumine is shown clinically comparable to standard of care liver MR with gadoxetate disodium for detecting hepatic metastasis from colorectal cancer, its use will save time, cost, and patients' effort.

Conditions

Oligometastatic Disease; Liver Metastases; Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

• Diagnostic Performance of gadobenate dimeglumine

  The primary performance diagnostic will be sensitivity, similar to the recently published retrospective study by Canellas et al. (2019). In addition to other diagnostic performance metrics of interest (e.g., specificity, AUROC), lesions will be analyzed descriptively in terms of number of metastases detected and lesion size.

  1 month

• Quantitative Measures of hepatobiliary phase images

  Mixed effects regression models will again be used to compare the three outcomes between methods, accounting for correlated data. The specific link function of the regression models will depend on the distributional characteristics of each outcome (e.g., logit link for dichotomous outcomes; linear regression for continuously measured outcomes).

  1 month

• Preference of radiologists for the images generated by amHBP versus aeHBP

  The quality of amHBP and aeHBP images will be assessed with ordinal response mixed effect models that include right/left image as a covariate. We will assess if there was any reader specific and/or general bias to prefer an image on the left or the right of a screen, regardless of the amHBP or aeHBP, and consider this when modeling the probability of preference of amHBP over aeHBP. We will estimate the relative probabilities of no-preference, amHBP preference, or aeHBP preference.

  1 month

Secondary Outcomes (4)

• Compare Sensitivity and Specificity,

  1 month

• Test Validity of Imaging Methods

  1 month

• Compare Patient Time Associated with Imaging Method

  1 month

• Compare Cost Associated with Imaging Method

  1 month

Study Arms (2)

Gadoxetate disodium exam first, Gadobenate Dimeglumine exam second

ACTIVE COMPARATOR

The subjects will be randomized into two groups. Both groups will undergo two complete protocol liver magnetic resonance imaging (MRI) for known or suspected colorectal cancer (CRC) metastasis, one exam with gadoxetate disodium and the other exam with gadobenate dimeglumine, within an interval of 3-10 days, but in opposite order, determined randomly.

Drug: Gadoxetate disodium; Drug: Gadobenate dimeglumine

Gadobenate Dimeglumine exam first, Gadoxetate disodium exam second

EXPERIMENTAL

The subjects will be randomized into two groups. Both groups will undergo two complete protocol liver MRI for known or suspected CRC metastasis, one exam with gadoxetate disodium and the other exam with gadobenate dimeglumine, within an interval of 3-10 days, but in opposite order, determined randomly.

Drug: Gadoxetate disodium; Drug: Gadobenate dimeglumine

Interventions

Gadoxetate disodium DRUG

Gadoxetate disodium MR contrast is now mainly used for the purpose of HBP liver MR imaging to save MR scanner time and total examination time.

Also known as: Primovist, Eovist

Gadobenate Dimeglumine exam first, Gadoxetate disodium exam second; Gadoxetate disodium exam first, Gadobenate Dimeglumine exam second

Gadobenate dimeglumine DRUG

The most commonly used MR contrast agent in abdominal imaging is gadobenate dimeglumine, which has mainly the characteristics of an extracellular agent used for most indications of MR examinations.

Also known as: MultiHance

Gadobenate Dimeglumine exam first, Gadoxetate disodium exam second; Gadoxetate disodium exam first, Gadobenate Dimeglumine exam second

Eligibility Criteria

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

You may qualify if:

• Colorectal cancer patients
• Age 18-80 years
• No prior treatment including surgery
• Prior imaging with suspected liver metastasis

You may not qualify if:

• Age \< 18 years or \> 80 years
• eGFR \< 30 ml/min/1.73 m2
• Previous reaction to gadolinium contrast agents
• History of claustrophobia or movement disorders likely to impact image quality
• Non-MR safe implants or metallic foreign bodies

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Bracco Diagnostics, Inc: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

gadolinium ethoxybenzyl DTPA; gadobenic acid

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Nikhil Madhuripan, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: We have attempted to mitigate any potential conflict of interest through randomization of the order of exams and blinding the image evaluators to contrast agents.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective study. The subjects will be randomized into two groups. Both groups will undergo two complete protocol liver MRs for known or suspected colorectal cancer (CRC) metastasis, one exam with gadoxetate disodium and the other exam with gadobenate dimeglumine, within an interval of 3-10 days, but in opposite order, determined randomly. From the complete protocol liver MR with both contrast agents, an image set of abbreviated HBP protocol liver MR for each agent will be obtained (Fig.1).Two week-intervals will be placed between the evaluations of different image sets of a patient, and the images will be presented in a different random order to each evaluating radiologist. The schedule of random order of protocol liver MRs and presentation of images to radiologists will be determined by the project biostatistician.

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 22, 2021
• Study Start: June 22, 2021
• Primary Completion: May 6, 2025
• Study Completion: May 8, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)