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).
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
233
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.
OHSU Knight Cancer Institute
Portland, Oregon, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Negative Predictive Value (NPV) of the diagnostic imaging (DW-MRI)
Time frame: 2 years after surgery
NPV of diagnostic imaging among the group of resected confirmed DLMs
Time frame: 2 years after the surgery
NPV of diagnostic imaging in the group of confirmed DLMs that were left in place
Time frame: 2 years after ther surgery
NPV of DW-MRI in the group of cDLMs diagnosed by central imaging review
Time frame: 2 years after the surgery
Correlation between different types of morphologic and ADC changes and TRG to the type of conversion therapy
Time frame: 2 years after the surgery
Correlation between findings on DW-MRI to histopathology, recurrence rate, complication rates, PFS and OS
Time frame: 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
Time frame: 2 years after initial surgery
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