Radioembolization for Liver Cancer

Phase 1

Waitlist Available

Led By Armeen Mahvash

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the side effects and best way to perform yttrium Y-90 radioembolization in treating patients with metastatic liver cancer.

Who is the study for?

This trial is for patients with liver cancer that has spread, who can understand and sign a consent form. It's suitable for those eligible for standard Y90 radioembolization treatment but not for patients where the cancer affects more than half of the liver.

What is being tested?

The study tests yttrium Y-90 radioembolization, which involves injecting radioactive particles into an artery to block blood flow to liver tumors. The focus is on doing this in one session to see if it's effective and more efficient.

What are the potential side effects?

Possible side effects include abdominal pain, nausea, fever, fatigue, and potential complications from radiation like damage to nearby organs or tissues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse event assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Angiogram

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (angiography, yttrium Y-90 radioembolization)Experimental Treatment7 Interventions

The first 2 patients enrolled receive standard of care diagnostic and treatment during 2 visits for approximately 6 hours each within 2-4 weeks. During the first visit, patients undergo diagnostic angiography with embolization of potential hepatoenteric collaterals, receive technetium Tc-99m albumin aggregated as a surrogate to the therapy microspheres via catheter, and undergo planar imaging. During the second visit, patients undergo a second angiography and receive yttrium Y 90 resin microspheres via arterial microcatheter. Patients then undergo single-photon emission computed tomography-computed tomography (SPECT-CT) Bremsstrahlung imaging. All subsequent patients enrolled undergo the same previously described diagnostic and treatment during 1 visit over about 8 hours.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Angiography

2014

N/A

~1900

Computed Tomography

2017

Completed Phase 2

~2790