Pilot Study to Assess Lung Shunting of Yttrium-90 Microspheres Using PET/CT
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|ClinicalTrials.gov Identifier: NCT02119065|
Recruitment Status : Active, not recruiting
First Posted : April 21, 2014
Last Update Posted : March 21, 2019
|Condition or disease||Intervention/treatment|
|Advanced Adult Primary Liver Cancer Liver Metastases Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer||Procedure: positron emission tomography Procedure: computed tomography|
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.
I. To quantify and compare the pre-therapy Technetium-99m macroaggregated albumin particle sizes and post-therapy Yttrium-90 microsphere sizes.
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.
|Study Type :||Observational|
|Actual Enrollment :||6 participants|
|Official Title:||PET/CT-Derived Hepatopulmonary Shunt Fraction Following Yttrium-90 Radioembolization|
|Actual Study Start Date :||January 30, 2014|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Health Services Research (PET/CT scan)
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.
Procedure: positron emission tomography
Undergo PET/CT scan
Procedure: computed tomography
Undergo PET/CT scan
Other Name: tomography, computed
- 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.
- In vitro Technetium-99m macroaggregated albumin particle size and microsphere size for each patient [ Time Frame: Baseline up to 24 months ]Descriptive statistical assessment of Technetium-99m macroaggregated albumin particle size and microsphere size for each patient (e.g., mean, median, standard deviation, distribution, etc.) will be performed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119065
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Michael Knopp, MD, PhD||Ohio State University Comprehensive Cancer Center|