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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA046934 | U.S. NIH Grant/Contract | View source |
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Low Accrual
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| Name | Class |
|---|---|
| Bracco Diagnostics, Inc | INDUSTRY |
| National Cancer Institute (NCI) | NIH |
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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.
The goal is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Compare Sensitivity and Specificity, | The primary analysis will use pathology as the gold standard, if available, but will revert to long term imaging in the absence of pathology. To address the potential impact of this limitation, we will also conduct an exploratory analysis to compare the sensitivity and specificity of the imaging methods by each gold standard. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nikhil Madhuripan, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 7, 2026 | Jun 2, 2026 | 9 | ||
| Jun 29, 2026 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C073590 | gadolinium ethoxybenzyl DTPA |
| C064572 | gadobenic acid |
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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.
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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.
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| 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. |
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| Test Validity of Imaging Methods | We will also conduct an exploratory analysis to test the validity of long term imaging as a gold standard against available pathology reports. | 1 month |
| Compare Patient Time Associated with Imaging Method | In addition to analyses for the primary aims, additional analyses will be conducted to examine patient time associated with each imaging method; time metrics can be compared between imaging methods in absolute terms, but also proportionally to sensitivity. | 1 month |
| Compare Cost Associated with Imaging Method | In addition to analyses for the primary aims, additional analyses will be conducted to examine cost associated with each imaging method; cost metrics can be compared between imaging methods in absolute terms, but also proportionally to sensitivity. | 1 month |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |