Diffusion-Weighted Magnetic REsonance Imaging Assessment of Liver Metastasis to Improve Surgical Planning (EORTC-1527-GITCG-IG/ JCOG1609INT, DREAM)

Not Applicable

Recruiting

• Conditions: colorectal liver metastases

• Registration Number: JPRN-UMIN000024890
• Lead Sponsor: European Organisation for Research and Treatment of Cancer (EORTC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-18
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: Open to public recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Criteria for registration
? Age >=18 years old
? Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations
Criteria for Eligibility
? Primary tumor histologically proven as colorectal adenocarcinoma
? Unresectable or borderline resectable liver metastases at the time of diagnosis for liver metastases.
? Presence of extrahepatic distant metastases is allowed as long as these lesions are considered as resectable
? Contrast-enhanced thorax, abdomen and pelvic CT scanat diagnosis is available
? Multiparametric MRI is available.
? No contraindications to any contrast agents for CT and MRI or MRI procedure
? WHO performance status of 0 or 1
? Previous treatments for primary, liver and extra-hepatic metastases are allowed.
? No significant comorbidity that will preclude either conversion therapy or surgery
? No other malignancies in the 3 years prior to study entry
? Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
? Pregnancy is a contraindication in this study.
Criteria for Enrollment
? At least 2 cycles of chemotherapy have been given as a part of conversion therapy. Any regimen and schedule of chemotherapy are allowed.
? At least 2 sets (at liver metastasis diagnosis and preoperative) of contrast-enhanced CT scan are available
? At least 2 sets of multiparametric MRI (baseline and preoperative) are available
? Interval between the two MRIs should be at least 4 weeks.
? Patient is suitable for hepatic resection based on the assessment of MDT prior to any liver surgery. MDT is composed of at least an expert liver/colorectal surgeon, Gastrointestinal (GI) radiologist and oncologist prior to any liver surgery. Attendance of pathologist is recommended
? Hepatic resection is scheduled within 8 weeks of latest imaging.

Exclusion Criteria

none

Study & Design

• Study Type: Interventional
• Study Design: Not specified