Liver MRI for Colorectal Cancer Liver Metastasis: Comparative Effectiveness Research for the Choice of Contrast Agents

NCT02652663 | Unknown

• 1 other identifier: 4-2015-1045
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Magnetic resonance imaging (MRI) has been widely used for problem-solving tool in the evaluation of hepatic lesions, and it has been shown to have better sensitivity than CT for detection of colorectal liver metastases, especially for lesions which are smaller than 1 cm. After introduction of a liver-specific hepatobiliary MR contrast agent, gadoxetic acid, gadoxetic acid-enhanced MRI (Gd-EOB-MRI) has been increasingly used for evaluation of liver lesion including CRLM. However, compared to conventional MRI with extracellular contrast agent (ECA-MRI), Gd-EOB-MRI has different pharmacodynamic characteristics, and is more expensive due to higher cost of gadoxetic acid and needs longer scan time to obtain hepatobiliary phase which is generally acquired 15 to 20 minutes after contrast injection. The purpose of this study was to compare the clinical outcome and diagnostic performance of Gd-EOB-MRI and ECA-MRI for evaluation of focal hepatic lesion in newly diagnosed colorectal cancer.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; liver; MRI; contrast; gadoxetic acid

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  From date of curative hepatic surgery until the date of first documented tumor recurrence or date of death from disease-related cause

  up to 120 months

Study Arms (2)

ECA-MRI group

ECA-MRI group (patients who underwent conventional MRI using extracellular contrast agent \[ECA\])

Gd-EOB-MRI group

Gd-EOB-MRI group (patients who underwent gadoxetic acid-enhanced MRI)

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed colorectal cancer between January 2005 and December 2010

You may qualify if:

• patients with surgically proven colorectal adenocarcinoma
• patients who underwent abdominopelvic CT and liver MRI for initial staging before any treatment
• no past or concurrent malignancy other than colorectal adenocarcinoma.

You may not qualify if:

• precontrast abdominopelvic CT
• precontrast liver MRI
• liver MRI using contrast other than extracellular agent or gadoxetic acid
• the interval between CT and liver MRI was longer than 4 weeks
• patients who had suspected multiple hepatic metastases (\> 10) on CT
• distant metastasis other than liver and
• unavailable reference standard of their hepatic lesions with no pathologic confirmation or follow up imaging.

Sponsors & Collaborators

• Yonsei University: lead

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 12, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 12, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share