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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Full Gadoxetate-enhanced liver MRI

    Diagnostic test

    Standard pulse sequences

  • Shortened Gadoxetate-enhanced liver MRI

    Diagnostic test

    Fewer pulse sequences

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Full ProtocolActive comparator 1 intervention
Group B: Abbreviated ProtocolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic accuracy of abbreviated versus full MRI protocol

Sensitivity, specificity, area under ROC curve

Time frame
2 years

Secondary outcomes

1

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)

Time frame
3 years
2

Overall survival at 1 year post abbreviated versus full MRI protocol

Proportion of patients alive at 1 year (dimensionless)

Time frame
3 years
3

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)

Time frame
3 years
4

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)

Time frame
3 years

Other outcomes

Sponsors and contacts

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