Gadoxetate Abbreviated MRI in Metastatic Colorectal Cancer

NCT05314400 | Recruiting

• 1 other identifier: 120191
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of abbreviated versus full MRI protocol

  Sensitivity, specificity, area under ROC curve

  2 years

Secondary Outcomes (6)

• Cost of abbreviated versus full MRI protocol

  3 years

• Overall survival at 1 year post abbreviated versus full MRI protocol

  3 years

• Cancer specific survival at 1 year post abbreviated versus full MRI protocol

  3 years

• Progression free survival at 1 year post abbreviated versus full MRI protocol

  3 years

• Diagnostic accuracy of simulated abbreviated versus full MRI protocol

  2 years

Study Arms (2)

Full Protocol

ACTIVE COMPARATOR

Routine Primovist MRI

Diagnostic Test: Full Gadoxetate-enhanced liver MRI

Abbreviated Protocol

EXPERIMENTAL

Shortened Primovist MRI

Diagnostic Test: Shortened Gadoxetate-enhanced liver MRI

Interventions

Full Gadoxetate-enhanced liver MRI DIAGNOSTIC_TEST

Standard pulse sequences

Full Protocol

Shortened Gadoxetate-enhanced liver MRI DIAGNOSTIC_TEST

Fewer pulse sequences

Abbreviated Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Bayer: collaborator

Study Sites (2)

St. Joseph's Healthcare

London, Ontario, N6A 4V2, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

RECRUITING

Related Publications (14)

• Canadian Cancer Statistics Advisory Committee in collaboration with the Canadian Cancer Society, Statistics Canada and the Public Health Agency of Canada. (2021).

  BACKGROUND

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• Kim JW, Lee CH, Park YS, Lee J, Kim KA. Abbreviated Gadoxetic Acid-enhanced MRI with Second-Shot Arterial Phase Imaging for Liver Metastasis Evaluation. Radiol Imaging Cancer. 2019 Sep 27;1(1):e190006. doi: 10.1148/rycan.2019190006. eCollection 2019 Sep.

  PMID: 33778670 BACKGROUND

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  PMID: 33211702 BACKGROUND

• Canellas R, Patel MJ, Agarwal S, Sahani DV. Lesion detection performance of an abbreviated gadoxetic acid-enhanced MRI protocol for colorectal liver metastasis surveillance. Eur Radiol. 2019 Nov;29(11):5852-5860. doi: 10.1007/s00330-019-06113-y. Epub 2019 Mar 19.

  PMID: 30888485 BACKGROUND

• Ghorra C, Pommier R, Piveteau A, Rubbia-Brandt L, Vilgrain V, Terraz S, Ronot M. The diagnostic performance of a simulated "short" gadoxetic acid-enhanced MRI protocol is similar to that of a conventional protocol for the detection of colorectal liver metastases. Eur Radiol. 2021 Apr;31(4):2451-2460. doi: 10.1007/s00330-020-07344-0. Epub 2020 Oct 6.

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• Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Mauer M, Tanis E, Van Cutsem E, Scheithauer W, Gruenberger T; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Federation Francophone de Cancerologie Digestive (FFCD). Perioperative FOLFOX4 chemotherapy and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC 40983): long-term results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2013 Nov;14(12):1208-15. doi: 10.1016/S1470-2045(13)70447-9. Epub 2013 Oct 11.

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Related Links

• Link to citation 1 (Canadian Cancer Statistics)

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Harry Marshall, MD/PhD

CONTACT

519-685-8500; harry.marshall@lhsc.on.ca

Zahra Kassam, MD

CONTACT

519-646-6100; zahra.kassam@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 6, 2022
• Study Start: July 1, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)