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Comparison of Contrast Agents in Liver MR for the Detection of Hepatic Metastases

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ClinicalTrials.gov Identifier: NCT04973007
Recruitment Status : Recruiting
First Posted : July 22, 2021
Last Update Posted : September 28, 2021
Sponsor:
Collaborators:
Bracco Diagnostics, Inc
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Oligometastatic Disease Liver Metastases Colorectal Cancer Drug: Gadoxetate disodium Drug: Gadobenate dimeglumine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
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.
Primary Purpose: Diagnostic
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
Actual Study Start Date : June 22, 2021
Estimated Primary Completion Date : August 9, 2023
Estimated Study Completion Date : December 9, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Gadoxetate disodium exam first
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.
Drug: Gadoxetate disodium
Gadoxetate disodium is now mainly used for the purpose of HBP liver MR imaging to save MR scanner time and total examination time.
Other Names:
  • Primovist
  • Eovist

Drug: Gadobenate dimeglumine
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.
Other Name: MultiHance

Active Comparator: Gadobenate Dimeglumine exam first
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.
Drug: Gadoxetate disodium
Gadoxetate disodium is now mainly used for the purpose of HBP liver MR imaging to save MR scanner time and total examination time.
Other Names:
  • Primovist
  • Eovist

Drug: Gadobenate dimeglumine
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.
Other Name: MultiHance




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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 Outcome Measures :
  1. Compare Sensitivity and Specificity, [ Time Frame: 1 month ]
    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.

  2. Test Validity of Imaging Methods [ Time Frame: 1 month ]
    We will also conduct an exploratory analysis to test the validity of long term imaging as a gold standard against available pathology reports.

  3. Compare Patient Time Associated with Imaging Method [ Time Frame: 1 month ]
    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.

  4. Compare Cost Associated with Imaging Method [ Time Frame: 1 month ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04973007


Contacts
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Contact: Samuel Chang, MD 720-848-0000 SAMUEL.CHANG@CUANSCHUTZ.EDU
Contact: Tracey MacDermott (303)724-2757 TRACEY.MACDERMOTT@CUANSCHUTZ.EDU

Locations
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United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Samuel Chang, MD    720-848-0000    Samuel.Chang@cuanschutz.edu   
Contact: Tracey MacDermott    (303)724-2757    TRACEY.MACDERMOTT@CUANSCHUTZ.EDU   
Principal Investigator: Samuel Chang, MD         
Sponsors and Collaborators
University of Colorado, Denver
Bracco Diagnostics, Inc
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Samuel Chang, MD University of Colorado, Denver
Publications:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04973007    
Other Study ID Numbers: 19-1045.cc
P30CA046934 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2021    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes