A Prospective Study Evaluating Diagnostic Accuracy, Outcome, and Economic Impact of Abbreviated Gadoxetate-enhanced MRI of the Liver in Patients With Metastatic Colorectal Carcinoma

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

After a patient is diagnosed with colon cancer, they receive a CT of the chest, abdomen, and pelvis to see if the cancer has spread (metastasized) to other parts of the body. A common site for the cancer to spread to is the liver. If an abnormality is seen in the liver on CT, sometimes an MRI of the liver is required to determine a) whether it is cancer or not and b) whether there are small tumours in the liver that were not visible on CT. During the MRI, the patient is injected with intravenous (IV) contrast. This makes liver lesions more conspicuous and also helps determine if they are cancerous or not. The most commonly used IV contrast agent is called Gadovist. However, there is another IV contrast agent called Primovist that is better at detecting liver metastases from colon cancer than Gadovist. This is very important information for surgeons, because if they considering cutting out (resecting) the liver tumours, they want to make sure they get them all. Unfortunately, Primovist is used sparingly in Canadian hospitals because it is more expensive than Gadovist and the MRI takes longer. Some early small studies have suggested that it may be possible to shorten the Primovist MRI significantly (e.g. from 60 minutes to 15 minutes), making it economically feasible to offer Primovist to more patients. However, there have not been any large studies performed to confirm these findings. The purpose of this study is to compare the accuracy of colon cancer liver metastasis detection between a regular, full-length Primovist MRI versus a shortened Primovist MRI protocol. The economic impact will also be assessed.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female, 18 years of age or older

• Diagnosis of colorectal cancer, biopsy proven

• Prior imaging showing liver lesions that may be metastases

• Provision of signed and dated informed consent form

• Willingness to comply with study procedures and availability for the duration of the study

• Able to tolerate MRI required by protocol

Locations
Other Locations
Canada
London Health Sciences Centre
RECRUITING
London
St. Joseph's Healthcare
RECRUITING
London
Contact Information
Primary
Harry Marshall, MD/PhD
harry.marshall@lhsc.on.ca
519-685-8500
Backup
Zahra Kassam, MD
zahra.kassam@sjhc.london.on.ca
519-646-6100
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 200
Treatments
Active_comparator: Full Protocol
Routine Primovist MRI
Experimental: Abbreviated Protocol
Shortened Primovist MRI
Related Therapeutic Areas
Sponsors
Collaborators: Bayer
Leads: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

This content was sourced from clinicaltrials.gov