NCT05195710

Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Patients With Colorectal Liver Metastases

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Metastases

Interventions

Type	Name	Description
DRUG	Yttrium-90 (Y-90) resin microspheres	Given by scan

Timeline

• Start date: 2022-11-16
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2022-01-19
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States