Clinical trial NCT04973007: Comparison of Contrast Agents in Liver MR for the Detection of Hepatic Metastases
Official title: Evaluation of Liver MR with an Abbreviated Gadobenate Dimeglumine Hepatobiliary Phase Protocol in Comparison to Liver MR with Gadoxetate Disodium for the Detection of Hepatic Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Oligometastatic Disease
Liver Metastases
Colorectal Cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Bracco Diagnostics, Inc
name: National Cancer Institute (NCI)
First posted: 2021-07-22
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 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.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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

Primary outcomes:
measure: Diagnostic Performance of gadobenate dimeglumine
timeFrame: 1 month
measure: Quantitative Measures of hepatobiliary phase images
timeFrame: 1 month
measure: Preference of radiologists for the images generated by amHBP versus aeHBP
timeFrame: 1 month
Secondary outcomes:
measure: Compare Sensitivity and Specificity,
timeFrame: 1 month
measure: Test Validity of Imaging Methods
timeFrame: 1 month
measure: Compare Patient Time Associated with Imaging Method
timeFrame: 1 month
measure: Compare Cost Associated with Imaging Method
timeFrame: 1 month
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Samuel Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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