Phase
Condition
Carcinoma
Liver Cancer
Neoplasms
Treatment
Stereotactic Body Radiation Therapy
Yttrium-90
Selective Internal Radiation Therapy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 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 effectivecontraception throughout the study and for 90 days following treatment.
Patients must understand and be willing to sign an informed consent form approvedfor this purpose by the Institutional Review Board (IRB) of the University ofMichigan Medical Center indicating that they are aware of the investigationalaspects of the treatment and the potential risks.
Exclusion
Exclusion Criteria:
Inability to lie still for imaging studies (e.g. PET/CT)
Pregnancy or nursing females or refusal to use birth control in patients capable ofreproduction.
Patients with known allergy or contraindication to intravenous iodinated contrastagents
Patients with an allergy or contraindication to MRI on MRI contrast (Eovist orGadolinium)
Contraindication to Theraspheres
Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphyshowing any deposition to the gastrointestinal tract that may not be correctedby angiographic techniques
Shunting of blood to the lungs that could result in delivery of greater than 30Gy to the lungs.
Hepatic artery catheterization contraindication; such as patients with vascularabnormalities or bleeding diathesis;
Bilirubin >2.0 at baseline
Occlusion of the main portal vein
Contraindication to radiation therapy
Note: Patients who have an increase in bilirubin >1.0 from the time of Y90 to SBRTor his/her bilirubin goes above 2.5 after Y90 will not be eligible for SBRT.
Study Design
Study Description
Connect with a study center
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
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