Actively Recruiting
Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.
Led by University of Michigan Rogel Cancer Center · Updated on 2025-08-05
70
Participants Needed
1
Research Sites
424 weeks
Total Duration
On this page
Sponsors
U
University of Michigan Rogel Cancer Center
Lead Sponsor
D
Department of Health and Human Services
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of unresectable hepatocellular carcinoma or metastatic liver cancer
- At least one liver tumor lesion larger than 2 cm in diameter or 4 cc in volume
- No known untreated or progressive disease outside the liver
- Life expectancy of at least 6 months
- Age 18 years or older
- Men and women of childbearing potential must agree to use effective contraception during the study and for 90 days after treatment
- Ability to understand and sign informed consent approved by the Institutional Review Board
You will not qualify if you...
- Inability to lie still for imaging studies such as PET/CT
- Pregnancy, nursing, or refusal to use birth control if capable of reproduction
- Known allergy or contraindication to intravenous iodinated contrast agents
- Allergy or contraindication to MRI contrast agents such as Eovist or Gadolinium
- Contraindications to Theraspheres including
- Deposition of radioactive material in the gastrointestinal tract not correctable by angiography
- Blood shunting to lungs exceeding safe radiation dose of 30 Gy
- Vascular abnormalities or bleeding disorders preventing hepatic artery catheterization
- Baseline bilirubin level over 2.0
- Occlusion of the main portal vein
- Contraindication to radiation therapy
- Bilirubin increase greater than 1.0 from Y-90 SIRT to SBRT or bilirubin above 2.5 after Y-90 SIRT
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
C
Cancer AnswerLine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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