Gadoxetate Abbreviated MRI in Metastatic Colorectal Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Presence of implanted medical device or metallic object that is MR incompatible

Baseline eGFR of < 30 mL/min/1.73 m2

Severe claustrophobia not relieved by oral anxiolytics

Documented severe allergic-like reaction gadolinium-based contrast agent

Trial design

Treatments tested in this trial

  • Full Gadoxetate-enhanced liver MRI
  • Shortened Gadoxetate-enhanced liver MRI

Treatment groups

200 Participants
are divided into 2 treatment groups

Locations

2
London Health Sciences CentreN6A5A5, LondonOntario, Canada
St. Joseph's HealthcareN6A 4V2, LondonOntario, Canada

Sponsors and collaborators

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead sponsor

Bayer

Collaborator