RecruitingPhase 1NCT04518748

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.


Sponsor

University of Michigan Rogel Cancer Center

Enrollment

70 participants

Start Date

Sep 16, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two types of radiation therapy — Y-90 SIRT (tiny radioactive beads delivered directly into liver tumors through a blood vessel) and SBRT (external targeted radiation) — is safe and effective for people with liver cancer that cannot be removed surgically. **You may be eligible if...** - You have been diagnosed with unresectable (inoperable) liver cancer, either primary liver cancer (HCC) or cancer that has spread to the liver from elsewhere - You are not a candidate for surgery - Your liver function is adequate to tolerate both procedures - You are in good enough general health to participate **You may NOT be eligible if...** - Your liver function is severely compromised (Child-Pugh C) - You have cancer that has spread widely beyond the liver - You have had prior full-dose radiation to the liver Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGYttrium-90

Radioactive isotope Y-90 at day 0, administered by selective internal radiation therapy (SIRT)

DEVICESelective Internal Radiation Therapy

SIRT at day 0, to administer Yttrium-90 (Y-90) Theraspheres

RADIATIONStereotactic Body Radiation Therapy

3-5 fractions over 1-2 weeks, after Y-90 SIRT

DIAGNOSTIC_TESTPET/CT

Within 3 hours of completing Y-90 SIRT

DEVICETherasphere

Glass microspheres containing Y-90, administered at day 0 by SIRT


Locations(1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

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NCT04518748