A Phase 1 Study of Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.
University of Michigan Rogel Cancer Center
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of unresectable hepatocellular carcinoma or metastatic liver cancer. Hepatocellular carcinoma is defined as having at least one of the following: * Biopsy proven hepatocellular carcinoma (HCC); or * A discrete hepatic tumor(s) as defined by the Barcelona imaging criteria. Metastatic liver cancer is defined as having: o pathological confirmation of any metastatic disease with a new or enlarging liver lesion consistent with metastases. The targeted lesion does not need to be biopsied if the patient has a known history of metastatic disease * Patients must…
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
Location
- University of Michigan Rogel Cancer CenterAnn Arbor, Michigan