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A phase 1 study of combined Y-90 selective internal radiation therapy (Y-90 SIRT) and stereotactic body radiation therapy (SBRT) in hepatic malignancy

Primary Investigator
Cuneo, Kyle
Status
OPEN TO ACCRUAL
Phase
I
NCT Number
NCT04518748
UM Number
2020.052
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Gastrointestinal Oncology
ID (Protocol)
13760
Secondary Protocol No
HUM00181352
Scope
Unspecified
Sponsor Type
Externally Peer-Reviewed
Disease Site
Liver
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: Inclusion Criteria
  •   Diagnosis of unresectable hepatocellular carcinoma. 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.
  •   Patients must not have known untreated extrahepatic cancer.
  •   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.
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 of reproduction.
  •   Patients with known allergy or contraindication to intravenous iodinated contrast agents
  •   Patients with an allergy or contraindication to MRI on MRI contrast (Eovist or Gadolinium)
  •   Contraindication to Theraspheres
    •   Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy showing any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques
    •   Shunting of blood to the lungs that could result in delivery of greater than 30 Gy to the lungs.
    •   Hepatic artery catheterization contraindication; such as patients with vascular abnormalities 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 SBRT or his/her bilirubin goes above 2.5 after Y90 will not be eligible for SBRT.