Lesion detection performance of an abbreviated gadoxetic acid-enhanced MRI protocol for colorectal liver metastasis surveillance.
Rodrigo Canellas, Midhir J Patel, Sheela Agarwal...
https://pubmed.ncbi.nlm.nih.gov/30888485/Actively Recruiting
Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2025-07-11
200
Participants Needed
2
Research Sites
52 weeks
Total Duration
Researchers are evaluating the accuracy and economic impact of two MRI protocols using the contrast agent gadoxetate Primovist to detect liver metastases in patients diagnosed with colorectal cancer. This study compares a full-length Primovist MRI protocol with a shortened version to see if the shorter exam can provide similar detection accuracy while reducing scan time and costs. The trial is prospective, randomized, and aims to improve imaging efficiency and patient management for colorectal liver metastases. Participants will be randomly assigned to receive either the routine full Primovist MRI or a shortened Primovist MRI with fewer pulse sequences. The baseline MRI scan will occur between 2 and 14 days after enrollment. Follow-up imaging with contrast-enhanced CT of the abdomen and pelvis will be performed one year later to assess cancer progression. The study plans to enroll 200 patients, with 100 in each group. During the trial, participants will undergo MRI scans with intravenous contrast to highlight liver lesions. Researchers will evaluate diagnostic accuracy, inter-reader agreement, survival outcomes at one year, and economic costs related to both MRI protocols and subsequent patient management. The primary outcome focuses on diagnostic accuracy over two years, while secondary outcomes include cost and survival data assessed over three years. Safety and tolerability of the MRI procedure will also be monitored throughout the study.
CONDITIONS
Gadoxetate Abbreviated MRI in Metastatic Colorectal Cancer
H
Harry Marshall, MD/PhD
Z
Zahra Kassam, MD
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
Bayer
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 2 weeks after screening
Participants undergo either a full or abbreviated gadoxetate-enhanced liver MRI to assess liver metastases from colorectal cancer.
1 baseline MRI visit (in-person)
Duration - 1 year
Participants are monitored for patient outcomes including overall survival, cancer-specific survival, and progression-free survival, with follow-up imaging to evaluate disease status.
1 follow-up CT scan visit approximately 1 year post-baseline (in-person)
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/15350579/London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
Bayer
Collaborating Sponsor