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RECRUITING
NCT04518748
PHASE1

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

Sponsor: University of Michigan Rogel Cancer Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2020-09-16

Completion Date

2028-11

Last Updated

2025-08-05

Healthy Volunteers

No

Interventions

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

Locations (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States