Diffusion-Weighted MRI for Liver Metastasis (DREAM)

Diffusion-Weighted Magnetic Resonance Imaging Assessment of Liver Metastasis to Improve Surgical Planning

The DREAM study will assess the diagnostic accuracy of diffusion-weighted MRI in combination with other imaging modalities (multiparametric MRI and CT Scan) in determining the true status of disappearing liver metastasis (DLM) detected after conversion systemic therapy for unresectable or borderline resectable colorectal liver metastasis (CRLM).

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colon Cancer Liver Metastasis; Malignant Neoplasm of Rectum Metastatic to Liver
• Intervention / Treatment: Procedure: DW-MRI

Detailed Description

The advancements of systemic and local therapies for complex CRLM have led to the increased incidence of DLMs. It is hypothesized that DW-MRI imaging could distinguish between a metastasis not completely sterilized by conversion therapy and a sterilized scar (non-viable tumor). If this can be demonstrated, the use of DW-MRI could make a significant impact on the surgical decision making process by providing surgeons a more reliable guide to decide whether to leave behind or to resect/ablate a site of DLM. Most importantly, this surgical choice can also have a significant impact on patient outcomes as it may impact the risk of local recurrence and the need for re-operation.The possibility of improving surgical management of complex CRLM is foreseen if the benefit of observing or resecting small residual metastases and DLMs is clarified through a multi-center and international prospective study.

• Study Type: Observational
• Enrollment (Actual): 233

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria
    • Innsbruck Universitaetsklinik
• Belgium
  • Ghent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Leuven, Belgium
    • U.Z. Leuven - Campus Gasthuisberg
• France
  • Bordeaux, France, 33076
    • Institut Bergonié
  • Lyon, France, 69008
    • Centre Léon Bérard
  • Villejuif, France
    • Gustave Roussy
• Japan
  • Chiba, Japan
    • Chiba Cancer Center
  • Gifu, Japan
    • Gifu University Hospital
  • Hiroshima, Japan
    • Hiroshima Prefectural Hospital
  • Hyōgo, Japan
    • Hyogo College of Medicine
  • Niigata, Japan
    • Niigata Prefectural Cancer Center Hospital
  • Osaka, Japan
    • Osaka Medical Center for Cancer and Cardiovascular Diseases
  • Ota-City, Japan
    • Gunma Cancer Center
  • Saitama, Japan
    • Jichi Medical University Saitama Medical Center
  • Shizuoka, Japan
    • Shizuoka Cancer Center
  • Tokyo, Japan
    • National Cancer Center Hospital
  • Tokyo, Japan
    • Tokyo Medical and Dental University
  • Yamagata, Japan
    • Yamagata Prefectural Central Hospital
  • Yokohama, Japan
    • Kanagawa Cancer Center
• United States
  • Oregon
    • Portland, Oregon, United States, 972639-3098
      • OHSU Knight Cancer Institute
  • Texas
    • Houston, Texas, United States, 77030-4009
      • The University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primary tumor histologically proven as colorectal adenocarcinoma, colorectal mucinous adenocarcinoma, colorectal signet ring cell carcinoma or colorectal adenosquamous carcinoma

Unresectable or borderline resectable liver metastases at the time of diagnosis for liver metastases. Both synchronous and metachronous metastases are allowed

Age ≥18 years old

With informed consent

Description

Inclusion Criteria for Eligibility:

1. Contrast-enhanced thorax, abdomen and pelvic CT scan (with at least portal venous phase for the liver) at diagnosis and right before surgery are available
2. Multiparametric MRI at baseline and right before surgery are available (T1/T2, DW-MRI and contrast enhanced MRI).
3. WHO performance status of 0 or 1
4. Previous treatments (chemotherapy, surgery) for primary, liver and extra-hepatic metastases are allowed.
5. No other malignancies in the 3 years prior to study entry with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer gleason score ≤ 6, and basal/squamous cell carcinoma of the skin
6. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the study

Criteria for Enrollment

1. Conversion therapy is either being given or completed
2. Patient is suitable for hepatic resection based on the assessment of MDT composed of at least an expert liver/colorectal surgeon, Gastrointestinal (GI) radiologist and oncologist prior to any liver surgery
3. Hepatic resection is scheduled to take place within 8 weeks of latest imaging

Exclusion Criteria:

1. Contraindications to any contrast agents for CT and MRI or MRI procedure
2. Pregnancy
3. Significant comorbidity that will preclude either conversion therapy or surgery

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Negative Predictive Value (NPV) of the diagnostic imaging (DW-MRI)	2 years after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
NPV of diagnostic imaging among the group of resected confirmed DLMs	2 years after the surgery
NPV of diagnostic imaging in the group of confirmed DLMs that were left in place	2 years after ther surgery
NPV of DW-MRI in the group of cDLMs diagnosed by central imaging review	2 years after the surgery
Correlation between different types of morphologic and ADC changes and TRG to the type of conversion therapy	2 years after the surgery
Correlation between findings on DW-MRI to histopathology, recurrence rate, complication rates, PFS and OS	2 years after initial surgery
Long term outcomes of patients who underwent surgery in terms of: - recurrence rates for 2 years after surgery - progression free survival for 2 years after surgery - overall survival for 2 years after surgery	2 years after initial surgery

Collaborators and Investigators

• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Collaborators: Japan Clinical Oncology Group; European Society of Surgical Oncology
• Investigators: Study Chair: Serge Evrard, Institut Bergonie, France

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): September 27, 2023
• Study Completion (Actual): September 27, 2023

Study Registration Dates

• First Submitted: May 17, 2016
• First Submitted That Met QC Criteria: May 20, 2016
• First Posted (Estimated): May 25, 2016

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: diffusion weighted MRI; unresectable colorectal liver metastasis; disappearing liver metastasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Liver Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasms; Neoplasm Metastasis; Body Weight; Rectal Neoplasms; Liver Neoplasms; Neoplasms, Second Primary
• Other Study ID Numbers: EORTC-1527-GITCG-IG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO