Diffusion-Weighted MRI for Liver Metastasis

Completed

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

• Registration Number: NCT02781935
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Timeline

• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-25
• Study Start: 2016-11
• Primary Completion: 2023-09-27
• Study Completion: 2023-09-27
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Negative Predictive Value (NPV) of the diagnostic imaging (DW-MRI)	2 years after surgery

Secondary Outcome Measures

Name	Time	Method
Correlation between different types of morphologic and ADC changes and TRG to the type of conversion therapy	2 years after the surgery
NPV of diagnostic imaging among the group of resected confirmed DLMs	2 years after the surgery
NPV of DW-MRI in the group of cDLMs diagnosed by central imaging review	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
NPV of diagnostic imaging in the group of confirmed DLMs that were left in place	2 years after ther 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

Trial Locations

Locations (21)

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

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