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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Full Gadoxetate-enhanced liver MRI
Diagnostic testStandard pulse sequences
Shortened Gadoxetate-enhanced liver MRI
Diagnostic testFewer pulse sequences
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic accuracy of abbreviated versus full MRI protocol
Sensitivity, specificity, area under ROC curve
Secondary outcomes
Cost of abbreviated versus full MRI protocol
Sum of the following dollar amounts: technical MRI fees + professional MRI fees + MRI time (cost per hour defined by local institution \* number hours used)
Overall survival at 1 year post abbreviated versus full MRI protocol
Proportion of patients alive at 1 year (dimensionless)
Cancer specific survival at 1 year post abbreviated versus full MRI protocol
1 - proportion of patients who died of colorectal cancer or its complications (dimensionless)
Progression free survival at 1 year post abbreviated versus full MRI protocol
1 - proportion of patients with evidence of recurrent or progressive hepatic disease at 1 year (dimensionless)
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