Recruiting

Gadoxetate MRI

Sponsor:

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

Code:

NCT05314400

Conditions

Liver Metastasis Colon Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Full Gadoxetate-enhanced liver MRI

Shortened Gadoxetate-enhanced liver MRI

Study Details

Brief 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.

Conditions

Liver Metastasis Colon Cancer

Study ID

NCT05314400

Start date

Jul 1, 2022

Status verified date

Jul, 2025

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Weight greater than allowable on MRI table
  • Pregnancy
  • Diffuse liver metastases, i.e. definitively unresectable
  • Severe liver dysfunction, ALBI grade 3

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Full Protocol

Routine Primovist MRI

experimental: Abbreviated Protocol

Shortened Primovist MRI

Interventions

Full Gadoxetate-enhanced liver MRI

Standard pulse sequences

Shortened Gadoxetate-enhanced liver MRI

Fewer pulse sequences

Primary outcome measure

  • Diagnostic accuracy of abbreviated versus full MRI protocol [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

St. Joseph's Healthcare

Recruiting

London, Ontario, Canada, N6A 4V2

Contacts

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A5A5

Contacts

More Information

Sponsor

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

Last update posted

Jul 11, 2025

Last verified

Jul, 2025

Keywords

  • Colorectal Cancer
  • Liver Metastasis
  • Gadoxetate (Primovist / Eovist)
  • Abbreviated MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2025-07-11.