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Y-90 Radioembolization for Liver Cancer

Phase 1
Recruiting
Led By Ching-Wei Tzeng, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Received at least four cycles (or two months) of chemotherapy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial is testing whether a treatment called Y-90 TARE can help control tumors on the right side of the liver, and if it can induce hypertrophy (growth) of the left liver as part of a planned hepatectomy.

Who is the study for?
This trial is for patients with colorectal liver metastases (CLM) who need surgery but have insufficient future liver remnant (FLR). Candidates must be medically fit for operation, mentally competent to consent, and have potentially curable CLM without extensive extrahepatic disease. They should not be pregnant or breastfeeding, nor suffer from conditions like high bilirubin levels, low platelets, albumin deficiency, portal hypertension or cirrhosis.Check my eligibility
What is being tested?
The study tests the safety of Y-90 TARE (radioembolization) in controlling tumors on one side of the liver and stimulating growth in the other part before a major hepatectomy. It's designed for those whose FLR is too small initially and aims to make a single-stage or two-stage liver resection possible.See study design
What are the potential side effects?
Y-90 resin microspheres may cause abdominal pain, nausea, fatigue post-treatment known as 'post-radioembolization syndrome', potential damage to nearby organs due to radiation exposure such as ulcers if it affects the stomach lining.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have completed at least four cycles or two months of chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The evaluation from using the 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.
The evaluation of using the safety 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.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Yttrium-90Experimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,314 Total Patients Enrolled
Sirtex MedicalIndustry Sponsor
28 Previous Clinical Trials
4,220 Total Patients Enrolled
Ching-Wei Tzeng, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Yttrium-90 (Y-90) resin microspheres Clinical Trial Eligibility Overview. Trial Name: NCT05195710 — Phase 1
Metastasis Research Study Groups: Yttrium-90
Metastasis Clinical Trial 2023: Yttrium-90 (Y-90) resin microspheres Highlights & Side Effects. Trial Name: NCT05195710 — Phase 1
Yttrium-90 (Y-90) resin microspheres 2023 Treatment Timeline for Medical Study. Trial Name: NCT05195710 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment period for this experiment ongoing?

"Affirmative. Clinicaltrials.gov has data that corroborates this trial is actively in search of participants, with the initial posting taking place on November 16th 2022 and the most recent update occurring one day later. The investigation requires 50 individuals to be drawn from a single medical centre."

Answered by AI

What is the total enrolment capacity of this clinical trial?

"Affirmative. The clinical trial is indeed recruiting, as evidenced by the information found on clinicaltrials.gov - it was initially posted on November 16th and last amended on the 17th of that month. A total of 50 individuals are sought to participate at a single location."

Answered by AI

Can Yttrium-90 (Y-90) resin microspheres be administered without any risk to health?

"Yttrium-90 (Y-90) resin microspheres has not been clinically evaluated a great deal, so its safety rating is 1 on our scale. This Phase 1 trial will provide data to support both efficacy and safety."

Answered by AI
~0 spots leftby Mar 2024