This trial evaluates whether gadobenate dimeglumine or gadoxetate disodium works better in magnetic resonance (MR) imaging for the diagnosis of patients with colorectal cancer that has spread to the liver (liver metastasis). Diagnostic procedures, such as MR, may help find and diagnose metastasis lesions.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04973007.
PRIMARY OBJECTIVE:
I. 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.
II. Estimate and compare quantitative measures of HBP images (liver enhancement ratio, lesion contrast to noise and signal to noise ratios [contrast to noise ratio (CNR) and signal to noise ratio (SNR)]) for both gadobenate dimeglumine and gadoxetate disodium.
III. 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.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo MR with gadoxetate disodium. After 3-20 days, patients undergo MR with gadobenate dimeglumine.
GROUP II: Patients undergo MR with gadobenate dimeglumine. After 3-20 days, patients undergo MR with gadoxetate disodium.
After completion of study, patients are followed up at 12 months.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUCHealth University of Colorado Hospital
Principal InvestigatorNikhil Madhuripan
