Metastases Clinical Trial
Official title:
Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Patients With Colorectal Liver Metastases
A prospective, interventional study evaluating the safety of Y-90 TARE for tumor control of the right side and induction of left liver hypertrophy as part of a planned single-stage or two-stage hepatectomy for patients with CLM and insufficient FLR at the time of presentation.
Primary Objective: To examine the safety and feasibility of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM. Secondary Objectives: - To describe changes in liver volume after Y-90 TARE, including: - The kinetic growth rate (KGR) of the FLR - Degree of hypertrophy 6 weeks after TARE - Atrophy of targeted right hemi-liver from TARE date to date of surgery - To describe additional interventional procedures needed to induce additional hypertrophy if insufficient hypertrophy from Y-90 TARE - To assess the proportion of TARE patients who undergo attempted and complete curative-intent resection of CLM - To assess measures of disease control, including: - Tumor marker trend - RECIST/mRECIST criteria - CT morphologic response - PET CT response - To describe Patient Reported Outcomes using MDASI-GI - To assess FLR liver quality, right-sided surgical adhesions from TARE intraoperatively - To describe dosimetry of individual liver lesions - using SPECT/CT, CT, and pathology correlation - To describe change in liver function measured by the pre- and post-TARE HIDA SPECT/CT scans and hepatic function blood tests ;
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