Oligometastatic DiseasePhase 4NCT04973007
Comparison of Contrast Agents in Liver Magnetic Resonance (MR) for the Detection of Hepatic Metastases
A Phase 4 study testing Gadoxetate disodium and Gadobenate dimeglumine in people with Oligometastatic Disease and Liver Metastases, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oligometastatic Disease, Liver Metastases, Colorectal Cancer
- What is being tested?
- Gadoxetate disodium and Gadobenate dimeglumine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2021to 8 May 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colorectal cancer patients
- Age 18-80 years
- No prior treatment including surgery
- Prior imaging with suspected liver metastasis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Evaluation of Liver Magnetic Resonance (MR) With an Abbreviated Gadobenate Dimeglumine Hepatobiliary Phase Protocol in Comparison to Liver MR With Gadoxetate Disodium for the Detection of Hepatic Metastases
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.
Read the 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.
- Conditions
- Oligometastatic Disease, Liver Metastases, Colorectal Cancer
- Being tested
- Gadoxetate disodium, Gadobenate dimeglumine
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadoxetate disodiumDrug
Also called Primovist, Eovist
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.
Gadobenate dimeglumineDrug
Also called MultiHance
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 3-20 days, but in opposite order, determined randomly. Receives: 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 3-20 days, but in opposite order, determined randomly. Receives: Drug: Gadoxetate disodium; Drug: Gadobenate dimeglumine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference of Radiologists for the Hepatobiliary Phase Images Generated by MultiHance (amHBP) Versus Eovist (aeHBP).
The quality of amHBP and aeHBP images was assessed using ordinal response mixed effect models that included right/left image position as a covariate. For each paired comparison, radiologists indicated their preferred hepatobiliary phase image.
Measured: 1 month
Quantitative Timing Measures for Hepatobiliary Phase MRI
Measures of timing used to obtain hepatobiliary phase images.
Measured: 1 month
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.
A single reader analyzed paired Eovist and MultiHance hepatobiliary phase images (N=10 paired datasets). Quantitative metrics included liver-to-metastasis, liver-to-spleen, liver-to-muscle, and liver-to-blood contrast ratios (CNR's), as well as liver signal-to-noise ratio (SNR). All CNR's were calculated as signal intensity of liver relative to the reference tissue, with liver SNR liver signal/liver noise. Higher contrast ratios and higher SNR values indicate greater liver enhancement and improved lesion conspicuity.
Measured: 1 month
Estimate and Compare Qualitative Measures of HBP Images for Both Gadobenate Dimeglumine and Gadoxetate Disodium.
A single reader performed a qualitative assessment of Dynamic and Hepatobiliary Phase Image Quality (Likert scale 1-5) for both Eovist and MultiHance Hepatobiliary Phase images (N=10 paired data). Higher scores indicate better image quality.
Measured: 1 month
Secondary outcomes (5)
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.
Measured: 1 year
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.
Measured: 17 months
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.
Measured: 17 months
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.
Measured: 17 months
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.
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start22 Jun 2021
- Primary completion6 May 2025
- Study completion8 May 2025
Why it stopped: Low Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oligometastatic DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 colorectal cancer (CRC) metastasis, one exam with gadoxetate disodium and the other exam with gadobenate dimeglumine, within an interval of 3-20 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Bracco Diagnostics, Inc, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nikhil Madhuripan, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973007
- Sponsor's protocol ID
- 19-1045.cc
- Other IDs
- P30CA046934
- Status last verified
- Aug 2026
- First submitted
- 1 Jul 2021
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No