PET/CT-Derived Hepatopulmonary Shunt Fraction Following Yttrium-90 Radioembolization
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Advanced Adult Primary Liver Cancer
- Sponsor
- University of Cincinnati
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Absolute difference in post-therapy Yttrium-90 microsphere and pre-therapy Technetium-99m macroaggregated albumin hepatopulmonary shunt fraction values
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
This pilot clinical trial studies positron emission tomography (PET)/computed tomography (CT) in finding beads after Yttrium-90 bead therapy in patients with primary liver cancer or cancer that has spread to the liver (metastatic) that can not be removed by surgery. Imaging procedures, such as PET/CT after Yttrium-90 bead therapy, may help see if the beads are present in the lung and compare the results with the pre-therapy imaging.
Detailed Description
PRIMARY OBJECTIVES: I. To estimate the absolute difference in post-therapy Yttrium-90 microsphere hepatopulmonary shunt fraction and the pre-therapy Technetium-99m macroaggregated albumin hepatopulmonary shunt fraction in patients with unresectable primary hepatic malignancy and hepatic metastatic disease. SECONDARY OBJECTIVES: I. To quantify and compare the pre-therapy Technetium-99m macroaggregated albumin particle sizes and post-therapy Yttrium-90 microsphere sizes. OUTLINE: Patients receive routine pre-therapy Technetium-99m macroaggregated albumin. Patients then undergo routine radioembolization with Yttrium-90 microspheres. Within 36 hours after radioembolization, patients undergo PET/CT imaging. Available imaging, clinical, interventional and surgical follow-up data for 2 years after completion of enrollment in the study will be obtained.
Investigators
Michael V Knopp MD PhD
Principal Investigator
University of Cincinnati
Eligibility Criteria
Inclusion Criteria
- •Patients who undergo intra-arterial hepatic 99mTc MAA evaluation in anticipation of 90Y microsphere radioembolization
Exclusion Criteria
- •Patients who are unable to give consent
- •Prisoners
Outcomes
Primary Outcomes
Absolute difference in post-therapy Yttrium-90 microsphere and pre-therapy Technetium-99m macroaggregated albumin hepatopulmonary shunt fraction values
Time Frame: Baseline to up to 36 hours after radioembolization
Non-parametric Wilcoxon signed rank testing will be used to compare the 99mTc MAA and 90Y microsphere shunt fractions. Alternatively, a natural log transformation of the hepatopulmonary shunt fractions may be used to normalize these data for subsequent parametric paired t-test analysis.
Secondary Outcomes
- In vitro Technetium-99m macroaggregated albumin particle size and microsphere size for each patient(Baseline up to 24 months)