Pilot Study to Assess Lung Shunting of Yttrium-90 Microspheres Using PET/CT

University of Cincinnati

Status: Active, not recruiting

Conditions: Advanced Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer; Liver Metastases; Localized Unresectable Adult Primary Liver Cancer

Treatments: Procedure: computed tomography; Procedure: positron emission tomography

Study type: Observational

Funder types: Other

Identifiers

NCT02119065

OSU-13176

NCI-2014-00278 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

6 participants in 1 patient group

Health Services Research (PET/CT scan)

Description:

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.

Treatment:

Procedure: positron emission tomography

Procedure: computed tomography