Diffusion-Weighted MRI for Liver Metastasis

NCT ID: NCT02781935

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 233 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2023-09-27

Brief Summary

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).

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.

Conditions

Colorectal Cancer; Colon Cancer Liver Metastasis; Malignant Neoplasm of Rectum Metastatic to Liver

Study Design

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

Interventions

DW-MRI

DW-MRI combined with Contrast Enhanced MRI will be used to confirm the status of disappearing liver metastasis prior to surgery and will be compared to findings from either histopathology of resected lesions (Rubbia-Brandt Classification of Tumor regression grading) or follow-up imaging of lesions left behind (either CT scan or MRI) after surgery. MRI will be used during the follow-up period to confirm recurrences from a previous site of DLM.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Japan Clinical Oncology Group

OTHER

Sponsor Role: collaborator

European Society of Surgical Oncology

OTHER

Sponsor Role: collaborator

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Serge Evrard

Role: STUDY_CHAIR

Institut Bergonie, France

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Innsbruck Universitaetsklinik

Innsbruck, , Austria

Universitair Ziekenhuis Gent

Ghent, , Belgium

U.Z. Leuven - Campus Gasthuisberg

Leuven, , Belgium

Institut Bergonie

Bordeaux, , France

Centre Leon Berard

Lyon, , France

Gustave Roussy

Villejuif, , France

Chiba Cancer Center

Chiba, , Japan

Gifu University Hospital

Gifu, , Japan

Hiroshima Prefectural Hospital

Hiroshima, , Japan

Hyogo College of Medicine

Hyōgo, , Japan

Niigata Prefectural Cancer Center Hospital

Niigata, , Japan

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka, , Japan

Gunma Cancer Center

Ōta-ku, , Japan

Jichi Medical University Saitama Medical Center

Saitama, , Japan

Shizuoka Cancer Center

Shizuoka, , Japan

National Cancer Center Hospital

Tokyo, , Japan

Tokyo Medical and Dental University

Tokyo, , Japan

Yamagata Prefectural Central Hospital

Yamagata, , Japan

Kanagawa Cancer Center

Yokohama, , Japan

Countries

United States; Austria; Belgium; France; Japan

References

Kataoka K, Mauer M, Shiozawa M, Marreaud S, Kishi Y, Cabrieto J, Onaya H, Ducreux M, Suto T, Kang HC, Matsuhashi N, Fung A, Yasui M, Rivoire M, Tonooka T, Troisi RI, Nakamura K, Stattner S, Kinugasa Y, Foo WC, Desolneux G, Bonhomme B, Ikeda M, Caballero C, Lordick F, Kanemitsu Y, Evrard S. Diagnostic Accuracy of Imaging in Assessing Nonviability of Disappearing Colorectal Liver Metastasis. JAMA Surg. 2025 Sep 17:e253600. doi: 10.1001/jamasurg.2025.3600. Online ahead of print.

Reference Type: DERIVED

PMID: 40960802 (View on PubMed)

Other Identifiers

EORTC-1527-GITCG-IG

Identifier Type: -

Identifier Source: org_study_id