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Terminated

NCT Number: NCT04973007

Comparison of Contrast Agents in Liver Magnetic Resonance (MR) 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.

Why the study stopped: Low Accrual
Terminated

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Key information

Conditions

Oligometastatic Disease Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Metastases Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Primovist, Eovist

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.

Other names: MultiHance

Primary outcomes

  1. 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.

  2. Quantitative Timing Measures for Hepatobiliary Phase MRI

    Time frame: 1 month

    Measures of timing used to obtain hepatobiliary phase images.

  3. 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.

  4. 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.

Secondary outcomes

  1. Diagnostic Performance of Gadobenate Dimeglumine

    Time frame: 1 year

    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. Compare Sensitivity and Specificity,

    Time frame: 17 months

    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.

  3. Test Validity of Imaging Methods

    Time frame: 17 months

    We will also conduct an exploratory analysis to test the validity of long term imaging as a gold standard against available pathology reports.

  4. Compare Patient Time Associated With Imaging Method

    Time frame: 17 months

    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.

  5. Compare Cost Associated With Imaging Method

    Time frame: 17 months

    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.

Interested in participating?

Terminated

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Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Bracco Diagnostics, Inc
  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2021
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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