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

Not Applicable

• 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

• Results First Posted: 1900-01-01
• Study Start: 2016-11-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Open 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

Primary Outcome Measures

Name	Time	Method
egative predictive value (NPV) of DW-MRI, T1/T2, CE-MRI and standard CT scan combined for the detection of non viable lesions after conversion therapy among those with confirmed DLMs that were either resected (using histopathology) or left behind (using imaging findings of absence of recurrence of the lesions within two years)