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| ID | Type | Description | Link |
|---|---|---|---|
| IRB#13-030 | Other Identifier | Fox Chase Cancer Center |
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This clinical trial studies positron emission tomography (PET)-computed tomography (CT) in determining the radiation dose delivered with radioactive spheres to patients with liver metastasis or primary liver or biliary cancer. Comparing results of diagnostic procedures dose before and after delivery of radioactive spheres to the liver may help determine radioembolization dose and plan the best treatment for liver metastasis or primary liver or biliary cancer.
PRIMARY OBJECTIVES:
I. To determine the relationship between radiation dose to 70% of the tumor volume as determined by post-treatment positron emission tomography (PET)-computed tomography (CT) and local control at 6 months.
SECONDARY OBJECTIVES:
I. To evaluate the ability of PET-CT to reproducibly determine dose to tumor, normal liver, and other surrounding organs.
II. To determine the stability of microsphere location by examining the changes in dose in a subset of patients with PET-CT scans performed on day 0 and day 1.
III. To determine the relationship of dose predicted by technetium-99m (Tc-99m) labeled Macro-aggregated albumin (MAA) imaged using single-photon emission computed tomography (SPECT) versus post-treatment dosimetry.
IV. To determine the effect of dose delivered on local control and normal tissue complications.
V. To measure the perfusion of the tumor for correlation with dose deposition, based on arterial phase CT measurements.
OUTLINE:
Patients undergo PET-CT scan before and after standard radioembolization on day 0. A subset of patients undergo PET-CT scan on day 1, 24 hours after the day 0 post-treatment PET-CT.
After completion of study treatment, patients are followed up at 1 week, 1 and 3 months, every 3 months for 1 year, every 6 months for 1 year and then annually for 3 years.
Although the study uses radiation-emitting imaging devices (PET/CT and SPECT) and standard-of-care Y-90 radioembolization, the clinical investigation does not study the performance, effect, safety, effectiveness, design, or intended use of an FDA-regulated device product. The research objectives are limited to characterization of radiation dose distribution and correlation of dosimetry with clinical outcomes; therefore, the study does not "Study a U.S. FDA-regulated Device Product" within the meaning of 42 CFR Part 11
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic: PET scan - CT scan | Experimental | Patients undergo PET-CT scan before and after standard radioembolization on day 0. A subset of patients undergo PET-CT scan on day 1, 24 hours after the day 0 post-treatment PET-CT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET scan | Procedure | Undergo PET-CT scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiation dose to 70% of the tumor volume, evaluated using PET-CT | Standard summary measures such as means, medians, ranges, and standard deviations will be used to characterize the dosages received by tumor and other tissue. The relationship between radiation dose and local control will be determined using regression models with Generalized Estimating Equations (GEE) to account for within-patient correlation. Logistic regression will be used to adjust for potentially confounding factors such as tumor volume, primary histology, and SIR-Spheres versus Therasphere intervention. | Up to day 1 |
| Local control | The relationship between radiation dose and local control will be determined using regression models with GEE to account for within-patient correlation. | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ability of PET-CT to reproducibly determine dose to tumor, normal liver, and other surrounding organs | Standard summary measures such as means, medians, ranges, and standard deviations will be used to characterize the dosages received by tumor and other tissue. | Up to day 1 |
| Side effects of radiation dose to healthy tissue such as fatigue, nausea, pain, and elevated liver function tests |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Meyer, MD | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2014 |
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| CT Scan | Procedure | Undergo PET-CT scan |
|
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| hepatic artery embolization | Procedure | Undergo standard radioembolization |
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Each side effect will be characterized as present or absent. The relationship between radiation dose to the relevant type of healthy tissue and each side effect will be tested. |
| Up to 5 years |
| Distribution of activity measured by PET-CT | Differences between PET-CT and MAA doses, and present the data graphically will be calculated and presented graphically. The method proposed by Bland & Altman (2007) will be used to assess the agreement between the two methods. | Up to day 1 |
| Distribution predicted by T-99m labeled MAA | Differences between PET-CT and MAA doses, and present the data graphically will be calculated and presented graphically. The method proposed by Bland & Altman (2007) will be used to assess the agreement between the two methods. | Baseline |
| Change in dose measured by PET-CT scan | Day 0 to day 1 |
| Feb 3, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 30, 2014 | Feb 3, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D001650 | Bile Duct Neoplasms |
| 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 |
| D001661 | Biliary Tract Neoplasms |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract 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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