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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04973007
• Other study ID #: 19-1045.cc
• Secondary ID: P30CA046934
• Status: Recruiting
• Phase: Phase 4
• Start date: June 22, 2021
• Est. completion date: December 9, 2024

Study information

• Verified date: September 2023
• Source: University of Colorado, Denver
• Contact: Samuel Chang, MD
• Phone: 720-848-0000
• Email: SAMUEL.CHANG[@]CUANSCHUTZ.EDU
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 9, 2024
• Est. primary completion date: August 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Liver Metastases
• Neoplasm Metastasis
• Oligometastatic Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Bracco Diagnostics, Inc, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (8)

Baek SE, Park MS, Hong HS, Choi JY, Chung YE, Lim JS, Kim MJ, Kim KW. Characterisation of small hypoattenuating hepatic lesions in multi-detector CT (MDCT) in patients with underlying extrahepatic malignancy: added value of contrast-enhanced MR images. Eur Radiol. 2010 Dec;20(12):2853-61. doi: 10.1007/s00330-010-1872-x. Epub 2010 Jul 9. — View Citation

Brismar TB, Dahlstrom N, Edsborg N, Persson A, Smedby O, Albiin N. Liver vessel enhancement by Gd-BOPTA and Gd-EOB-DTPA: a comparison in healthy volunteers. Acta Radiol. 2009 Sep;50(7):709-15. doi: 10.1080/02841850903055603. — View Citation

Canellas R, Patel MJ, Agarwal S, Sahani DV. Lesion detection performance of an abbreviated gadoxetic acid-enhanced MRI protocol for colorectal liver metastasis surveillance. Eur Radiol. 2019 Nov;29(11):5852-5860. doi: 10.1007/s00330-019-06113-y. Epub 2019 Mar 19. — View Citation

Hardie AD, Naik M, Hecht EM, Chandarana H, Mannelli L, Babb JS, Taouli B. Diagnosis of liver metastases: value of diffusion-weighted MRI compared with gadolinium-enhanced MRI. Eur Radiol. 2010 Jun;20(6):1431-41. doi: 10.1007/s00330-009-1695-9. Epub 2010 Feb 11. — View Citation

Kenis C, Deckers F, De Foer B, Van Mieghem F, Van Laere S, Pouillon M. Diagnosis of liver metastases: can diffusion-weighted imaging (DWI) be used as a stand alone sequence? Eur J Radiol. 2012 May;81(5):1016-23. doi: 10.1016/j.ejrad.2011.02.019. Epub 2011 Mar 4. — View Citation

Schulz A, Viktil E, Godt JC, Johansen CK, Dormagen JB, Holtedahl JE, Labori KJ, Bach-Gansmo T, Klow NE. Diagnostic performance of CT, MRI and PET/CT in patients with suspected colorectal liver metastases: the superiority of MRI. Acta Radiol. 2016 Sep;57(9):1040-8. doi: 10.1177/0284185115617349. Epub 2015 Nov 29. — View Citation

Zech CJ, Herrmann KA, Reiser MF, Schoenberg SO. MR imaging in patients with suspected liver metastases: value of liver-specific contrast agent Gd-EOB-DTPA. Magn Reson Med Sci. 2007;6(1):43-52. doi: 10.2463/mrms.6.43. — View Citation

Zhang L, Yu X, Huo L, Lu L, Pan X, Jia N, Fan X, Morana G, Grazioli L, Schneider G. Detection of liver metastases on gadobenate dimeglumine-enhanced MRI: systematic review, meta-analysis, and similarities with gadoxetate-enhanced MRI. Eur Radiol. 2019 Oct;29(10):5205-5216. doi: 10.1007/s00330-019-06110-1. Epub 2019 Mar 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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