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
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Preference of Radiologists for the Hepatobiliary Phase Images Generated by MultiHance (amHBP) Versus Eovist (aeHBP).
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Gadoxetate disodium exam first, Gadobenate Dimeglumine exam second
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.
Intervention: Gadoxetate disodium (Drug)
Gadoxetate disodium exam first, Gadobenate Dimeglumine exam second
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.
Intervention: Gadobenate dimeglumine (Drug)
Gadobenate Dimeglumine exam first, Gadoxetate disodium exam second
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.
Intervention: Gadoxetate disodium (Drug)
Gadobenate Dimeglumine exam first, Gadoxetate disodium exam second
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.
Intervention: Gadobenate dimeglumine (Drug)
Outcomes
Primary Outcomes
Preference of Radiologists for the Hepatobiliary Phase Images Generated by MultiHance (amHBP) Versus Eovist (aeHBP).
Time Frame: 1 month
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.
Quantitative Timing Measures for Hepatobiliary Phase MRI
Time Frame: 1 month
Measures of timing used to obtain hepatobiliary phase images.
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.
Time Frame: 1 month
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.
Estimate and Compare Qualitative Measures of HBP Images for Both Gadobenate Dimeglumine and Gadoxetate Disodium.
Time Frame: 1 month
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.
Diagnostic Performance of gadobenate dimeglumine
Time Frame: 1 month
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.
Quantitative Measures of hepatobiliary phase images
Time Frame: 1 month
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).
Preference of radiologists for the images generated by amHBP versus aeHBP
Time Frame: 1 month
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.
Secondary Outcomes
- Diagnostic Performance of Gadobenate Dimeglumine(1 year)
- Compare Sensitivity and Specificity,(17 months)
- Test Validity of Imaging Methods(17 months)
- Compare Patient Time Associated With Imaging Method(17 months)
- Compare Cost Associated With Imaging Method(17 months)
- Compare Sensitivity and Specificity,(1 month)
- Test Validity of Imaging Methods(1 month)
- Compare Patient Time Associated with Imaging Method(1 month)
- Compare Cost Associated with Imaging Method(1 month)