NCT02781935

Diffusion-Weighted MRI for Liver Metastasis

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 233 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2016-11-01
• Primary completion: 2023-09-27
• Completion: 2023-09-27
• First posted: 2016-05-25
• Last updated: 2024-01-05

Locations

21 sites across 5 countries: United States, Austria, Belgium, France, Japan