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

NCT ID: NCT02652663

Last Updated: 2016-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

ECA-MRI group

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

No interventions assigned to this group

Gd-EOB-MRI group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. patients with surgically proven colorectal adenocarcinoma

2. patients who underwent abdominopelvic CT and liver MRI for initial staging before any treatment

3. no past or concurrent malignancy other than colorectal adenocarcinoma.

Exclusion Criteria

1. precontrast abdominopelvic CT

2. precontrast liver MRI

3. liver MRI using contrast other than extracellular agent or gadoxetic acid

4. the interval between CT and liver MRI was longer than 4 weeks

5. patients who had suspected multiple hepatic metastases (> 10) on CT

6. distant metastasis other than liver and

7. unavailable reference standard of their hepatic lesions with no pathologic confirmation or follow up imaging.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

4-2015-1045

Identifier Type: -

Identifier Source: org_study_id