A Phase 1 Study of Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.
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.
• 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 not have known untreated or progressive disease outside of the liver
• At least one lesion \>2 cm diameter or 4 cc volume
• Patients must have a life expectancy of at least 6 months.
• Patients must be 18 years of age or older
• All men, as well as women of childbearing potential, must agree to use effective contraception throughout the study and for 90 days following treatment.
• Patients must understand and be willing to sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.