NCT04518748

Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.

A Phase 1 Study of Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the combination of Ytrium-90 (Y-90) Selective Internal Radiation Therapy (SIRT) followed by Stereotactic Body Radiation Therapy (SBRT). Y-90 SIRT alone or SBRT alone are standard procedures used in the treatment of liver cancer. This study will assess the combination of Y-90 SIRT and SBRT and obtain preliminary information about the side effects and safety of the combination therapy. Additionally, this is the first time that Y-90 PET-CT imaging will be included in planning for SBRT.

Detailed description

Selective Internal Radiation Therapy (SIRT) is a technique where radiation is internally delivered to a tumor. In SIRT, small radioactive beads are deposited in the liver through a large blood vessel (hepatic artery). SIRT that uses the radioactive material Yttrium-90 is called Y-90 SIRT. Stereotactic Body Radiation Therapy (SBRT) is a technique where radiation is externally delivered to a tumor. In SBRT, a machine produces a beam of radiation that targets the tumor from outside the body. After receiving Y-90 SIRT, participants will be evaluated to estimate how much radiation was absorbed by their tumors during Y-90 SIRT. Y-90 PET-CT imaging will be used to help plan SBRT, which will target areas of tumors that did not receive as much radiation as expected during Y-90 SIRT. Updated to add 5 patients to enrollment goal to achieve desired number of evaluable patients Since patients treated with Y-90 for any liver malignancy can benefit from the Y-90+SBRT combined treatment approach we have decided to open up the protocol to all eligible patients and not HCC alone.

Conditions

• Liver Malignancy

Interventions

Type	Name	Description
DRUG	Yttrium-90	Radioactive isotope Y-90 at day 0, administered by selective internal radiation therapy (SIRT)
DEVICE	Selective Internal Radiation Therapy	SIRT at day 0, to administer Yttrium-90 (Y-90) Theraspheres
RADIATION	Stereotactic Body Radiation Therapy	3-5 fractions over 1-2 weeks, after Y-90 SIRT
DIAGNOSTIC_TEST	PET/CT	Within 3 hours of completing Y-90 SIRT
DEVICE	Therasphere	Glass microspheres containing Y-90, administered at day 0 by SIRT

Timeline

• Start date: 2020-09-16
• Primary completion: 2028-05-01
• Completion: 2028-11-01
• First posted: 2020-08-19
• Last updated: 2025-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study