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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00278 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| positron emission tomography | Procedure | Undergo PET/CT scan |
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute difference in post-therapy Yttrium-90 microsphere and pre-therapy Technetium-99m macroaggregated albumin hepatopulmonary shunt fraction values | 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. | Baseline to up to 36 hours after radioembolization |
| Measure | Description | Time Frame |
|---|---|---|
| In vitro Technetium-99m macroaggregated albumin particle size and microsphere size for each patient | 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. | Baseline up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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The target population includes patients with unresectable liver metastases or malignancy who are referred to The Ohio State University Wexner Medical Center for Yttrium-90 microsphere radioembolization therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Knopp, MD, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| computed tomography | Procedure | Undergo PET/CT scan |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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