Trials / Active Not Recruiting
Active Not RecruitingNCT02119065
Pilot Study to Assess Lung Shunting of Yttrium-90 Microspheres Using PET/CT
PET/CT-Derived Hepatopulmonary Shunt Fraction Following Yttrium-90 Radioembolization
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 6 (actual)
- Sponsor
- University of Cincinnati · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Advanced Adult Primary Liver Cancer
- Liver Metastases
- Localized Unresectable Adult Primary Liver Cancer
- Recurrent Adult Primary Liver Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | positron emission tomography | Undergo PET/CT scan |
| PROCEDURE | computed tomography | Undergo PET/CT scan |
Timeline
- Start date
- 2014-01-30
- Primary completion
- 2015-07-01
- Completion
- 2026-12-31
- First posted
- 2014-04-21
- Last updated
- 2025-04-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02119065. Inclusion in this directory is not an endorsement.