Overview

This trial is active, not recruiting.

Conditions advanced adult primary liver cancer, liver metastases, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer
Treatments positron emission tomography, computed tomography
Sponsor Ohio State University Comprehensive Cancer Center
Start date January 2014
End date July 2015
Trial size 60 participants
Trial identifier NCT02119065, NCI-2014-00278, OSU-13176

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients receive routine pre-therapy technetium Tc 99m-labeled macroaggregated albumin. Patients then undergo routine radioembolization with yttrium Y 90 resin microspheres. Within 36 hours after radioembolization, patients undergo PET/CT imaging.
positron emission tomography PET
Undergo PET/CT scan
computed tomography tomography, computed
Undergo PET/CT scan

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
In vitro Technetium-99m macroaggregated albumin particle size and microsphere size for each patient
time frame: Baseline up to 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title PET/CT-Derived Hepatopulmonary Shunt Fraction Following Yttrium-90 Radioembolization
Principal investigator Chadwick Wright
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.