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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Borderline resectable unresectable (due to insufficient liver volume at presentation) colorectal liver metastases with potential curative intent, as determined by the surgeon and multidisciplinary team

• Anticipated standardized FLR (sFLR) that would require right portal vein embolization (PVE) to increase the sFLR prior to either a single major hepatectomy, or prior to the second stage hepatectomy as part of a two-stage hepatectomy strategy, all in the setting of curative-intent resection(s). This evaluation will be documented in the clinical chart

• Received at least four cycles (or two months) of chemotherapy

• Willing, able and mentally competent to provide written informed consent

• Medically and physically operable as determined by the surgeon

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Ching-Wei Tzeng, MD
cdtzeng@mdanderson.org
(713) 792-0386
Time Frame
Start Date: 2022-11-16
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 50
Treatments
Experimental: Yttrium-90
Help to control the tumor(s) on the right side of the liver while the remaining left side of the liver, which is clear of cancer, grows.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: Sirtex Medical

This content was sourced from clinicaltrials.gov