Comparison of Contrast Agents in Liver MR for the Detection of Hepatic Metastases

Sponsor: University of Colorado, Denver

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04973007

Patient View

This trial evaluates the diagnostic performance of abbreviated liver MR protocols using gadobenate dimeglumine versus gadoxetate disodium in detecting liver metastases in colorectal cancer patients aged 18-80. It compares sensitivity, specificity, and image quality, and assesses radiologist preferences. Participants must have suspected liver metastasis and no prior treatment.

Patient Parameters

Program Overview

If an abbreviated 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.

Description

The goal is to:

  • Estimate and compare the diagnostic performance, including sensitivity, specificity, positive/negative predictive value, and area under the receiver operating characteristics (AUROC), of abbreviated protocol liver magnetic resonance (MR) with hepatobiliary phase (HBP) using gadobenate dimeglumine for detecting liver metastases, with 1) abbreviated protocol liver MR with HBP using gadoxetate disodium, 2) standard of care complete protocol liver MR using gadoxetate disodium, and 3) complete protocol liver MR using gadobenate dimeglumine.
  • Estimate and compare quantitative measures of HBP images (liver enhancement ratio, lesion contrast to noise and signal to noise ratios [CNR and SNR]) for both gadobenate dimeglumine and gadoxetate disodium.
  • Qualitatively assess the preference, or lack thereof, of radiologists regarding the images generated by abbreviated protocol liver MR with HBP using gadobenate dimeglumine versus abbreviated protocol liver MR with HBP using gadoxetate disodium.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

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