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The TheraSphere Post-Approval Study is a post-market, prospective, single-arm, open-label, observational study to support the use of TheraSphere for the treatment of hepatocellular carcinoma (HCC).
Every patient being treated with TheraSphere needs to have a screening procedure with the administration of a radioactive product named Tc-99m MAA (called pre-treatment mapping). This screening procedure aims to determine if the patient can be treated with TheraSphere. The purpose of this study is to better understand the dose of radiation that is absorbed by the body and the risk of Tc-99m MAA to the whole body and other organs around the liver. The study will determine the amount of Tc-99m MAA that stays in the body and organs up to 24 hours after the administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Cohort | Patients enrolled in the study will have 3 imaging scans taken after Tc-99m MAA injection. The final scan will occur between 18 and 24 hours after Tc-99m MAA injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technetium-99m macroaggregated albumin (Tc-99m MAA) | Device | Patients who are being evaluated for TheraSphere administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delivered Activity of Tc-99m MAA (MBq) for Whole Body | To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body. | Immediately following |
| Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs | To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs. | Immediately following |
| Delivered Activity of Tc-99m MAA (MBq) for Whole Body | To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body. | 4 hours +/- 2 hours |
| Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs. | To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs. | 4 hours +/- 2 hours |
| Delivered Activity of Tc-99m MAA (MBq) for Whole Body. | To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body following injection. | 18-24 hours |
| Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs | To provide imaging data to calculate radiation delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs. | 18-24 hours |
| Absorbed Dose of Tc-99m MAA (mGy) for Whole Body. |
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Inclusion Criteria:
Exclusion Criteria:
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The intended population for the TheraSphere Post-Approval study is patients with HCC who are undergoing evaluation to assess eligibility for TheraSphere treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Riad Salem, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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This study was conducted at one clinical study site, NWU in Chicago, IL USA. Six patients consented and enrolled. Patient considered enrolled at time of consent per protocol. Patient 001 withdrew consent prior to the Tc-99m MAA procedure. Five patients received protocol required imaging after Tc-99m MAA injections.
Patient # Date of Enrollment:
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| ID | Title | Description |
|---|---|---|
| FG000 | Clinical Cohort | Patients enrolled in the study will have 3 imaging scans taken after Tc-99m MAA injection. The final scan will occur between 18 and 24 hours after Tc-99m MAA injection. Technetium-99m macroaggregated albumin (Tc-99m MAA): Patients who are being evaluated for TheraSphere administration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinical Cohort | Patients enrolled in the study will have 3 imaging scans taken after Tc-99m MAA injection. The final scan will occur between 18 and 24 hours after Tc-99m MAA injection. Technetium-99m macroaggregated albumin (Tc-99m MAA): Patients who are being evaluated for TheraSphere administration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Delivered Activity of Tc-99m MAA (MBq) for Whole Body | To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body. | Patients who are being evaluated for TheraSphere administration. | Posted | Mean | Full Range | MBq | Immediately following |
|
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Procedure-related Serious Adverse Events were assessed immediately following Tc-99m MAA injection, 4 hours (+ or = to 2 hours) following Tc-99m MAA injection, > or = to 18 hours but < or = to 24 hours following Tc-99m MAA injection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clinical Cohort | Patients enrolled in the study will have 3 imaging scans taken after Tc-99m MAA injection. The final scan will occur between 18 and 24 hours after Tc-99m MAA injection. Technetium-99m macroaggregated albumin (Tc-99m MAA): Patients who are being evaluated for TheraSphere administration. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessie Stockwell, Sr. Clinical Trial Specialist | Boston Scientific | 6126181136 | jessie.stockwell@bsci.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 31, 2022 | Jul 29, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 4, 2023 | Jul 29, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to the whole body. |
| Overall |
| Absorbed Dose of Tc-99m MAA (mGy) for Non-Liver Critical Organs | To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to Non-Liver Critical Organs. | Overall |
| Effective Dose of Tc-99m MAA (mSv) Whole Body | To provide imaging data calculating radiation-effective does of Tc-99m MAA to Non-Liver Critical Organs. | Overall |
| Effective Dose of Tc-99m MAA (mSv/mBq) for Whole Body | To provide data calculating radiation-effective dose of Tc-99m MAA to Whole Body. | Overall |
| Equivalent Dose of TC-99m MAA (mSV) for Non-Liver Critical Organs | To provide imaging data calculating radiation-equivalent dose of Tc-99m MAA to Non-Liver Critical Organs. | Overall |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs | To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs. | Patients who are being evaluated for TheraSphere administration. | Posted | Mean | Full Range | MBq | Immediately following |
|
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| Primary | Delivered Activity of Tc-99m MAA (MBq) for Whole Body | To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body. | Patients who are being evaluated for TheraSphere administration. | Posted | Mean | Full Range | MBq | 4 hours +/- 2 hours |
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| Primary | Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs. | To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs. | Patients who are being evaluated for TheraSphere administration. | Posted | Mean | Full Range | MBq | 4 hours +/- 2 hours |
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| Primary | Delivered Activity of Tc-99m MAA (MBq) for Whole Body. | To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body following injection. | Patients who are being evaluated for TheraSphere administration. | Posted | Mean | Full Range | MBq | 18-24 hours |
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| Primary | Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs | To provide imaging data to calculate radiation delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs. | Patients who are being evaluated for TheraSphere administration. | Posted | Mean | Full Range | MBq | 18-24 hours |
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| Primary | Absorbed Dose of Tc-99m MAA (mGy) for Whole Body. | To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to the whole body. | Patients who are being evaluated for TheraSphere administration. | Posted | Mean | Full Range | mGy | Overall |
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| Primary | Absorbed Dose of Tc-99m MAA (mGy) for Non-Liver Critical Organs | To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to Non-Liver Critical Organs. | Patient who are being evaluated for TheraSphere administration. | Posted | Mean | Full Range | mGy | Overall |
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| Primary | Effective Dose of Tc-99m MAA (mSv) Whole Body | To provide imaging data calculating radiation-effective does of Tc-99m MAA to Non-Liver Critical Organs. | Patients who are being evaluated for TheraSphere administration. | Posted | Mean | Full Range | mSv | Overall |
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| Primary | Effective Dose of Tc-99m MAA (mSv/mBq) for Whole Body | To provide data calculating radiation-effective dose of Tc-99m MAA to Whole Body. | Patients who are being evaluated for TheraSphere administration. | Posted | Median | Inter-Quartile Range | mSv/mBq | Overall |
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| Primary | Equivalent Dose of TC-99m MAA (mSV) for Non-Liver Critical Organs | To provide imaging data calculating radiation-equivalent dose of Tc-99m MAA to Non-Liver Critical Organs. | Patients who are being evaluated for TheraSphere administration. | Posted | Mean | Full Range | mSv | Overall |
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| 0 |
| 5 |
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| 5 |
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