Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bright Research Partners | INDUSTRY |
Not provided
Not provided
Not provided
The goal of this interventional clinical trial is to evaluate the dose of radiation of Technetium-99m macroaggregated-albumin (99mTc-MAA) after an intra-arterial injection to the whole body and non-liver critical organs in patients who are undergoing evaluation for SIR-Spheres treatment for hepatocellular carcinoma.
The investigation is a prospective, single center, open label, single-arm study. Patients enrolled in the study will have 3 imaging scans taken after 99mTc-MAA injection, the final of which will occur between 18 and 24 hours post-injection.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 99mTc-MAA Injection | Other | Patients enrolled in the study will have 3 imaging scans taken after 99mTc-MAA Injection with the final scan occurring 18-24 hours after injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 99mTc-Macro Albumin Aggregate | Drug | Technetium-99m macroaggregated-albumin consists of macroaggregated-albumin particles labeled with technetium-99m (99mTc), with a size between 10 and 90 microns in diameter. 99mTc is a gamma emitting radioactive isotope commonly used for diagnostic localization studies. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Absorbed Dose (Gy) for the Whole Body | 18-24 hours | |
| Mean Absorbed Dose (Gy) for Critical Non-liver Organs | 18-24 hours | |
| Mean Activity (Bq) for the Whole Body | 18-24 hours | |
| Mean Activity (Bq) for Critical Non-liver Organs | 18-24 hours | |
| Effective Dose (Gy) for the Whole Body | 18-24 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Douglas Murrey, MD | Inland Imaging | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inland Imaging | Spokane | Washington | 99208 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26089551 | Background | Gates VL, Singh N, Lewandowski RJ, Spies S, Salem R. Intraarterial Hepatic SPECT/CT Imaging Using 99mTc-Macroaggregated Albumin in Preparation for Radioembolization. J Nucl Med. 2015 Aug;56(8):1157-62. doi: 10.2967/jnumed.114.153346. Epub 2015 Jun 18. | |
| 35612924 | Background | Kappadath SC, Lopez BP. Organ-level internal dosimetry for intra-hepatic-arterial administration of 99m Tc-macroaggregated albumin. Med Phys. 2022 Aug;49(8):5504-5512. doi: 10.1002/mp.15726. Epub 2022 Jun 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 99mTc-MAA Injection | Patients enrolled in the study had 3 imaging scans taken after 99mTc-MAA Injection with the final scan occurring 18-24 hours after injection. 99mTc-Macro Albumin Aggregate: Technetium-99m macroaggregated-albumin consists of macroaggregated-albumin particles labeled with technetium-99m (99mTc), with a size between 10 and 90 microns in diameter. 99mTc is a gamma emitting radioactive isotope commonly used for diagnostic localization studies. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 99mTc-MAA Injection | Patients enrolled in the study will have 3 imaging scans taken after 99mTc-MAA Injection with the final scan occurring 18-24 hours after injection. 99mTc-Macro Albumin Aggregate: Technetium-99m macroaggregated-albumin consists of macroaggregated-albumin particles labeled with technetium-99m (99mTc), with a size between 10 and 90 microns in diameter. 99mTc is a gamma emitting radioactive isotope commonly used for diagnostic localization studies. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Absorbed Dose (Gy) for the Whole Body | Posted | Mean | Standard Deviation | mGy | 18-24 hours |
|
|
Adverse event data was collected from the procedure until 18-24 hours post-procedure.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 99mTc-MAA Injection | Patients enrolled in the study had 3 imaging scans taken after 99mTc-MAA Injection with the final scan occurring 18-24 hours after injection. 99mTc-Macro Albumin Aggregate: Technetium-99m macroaggregated-albumin consists of macroaggregated-albumin particles labeled with technetium-99m (99mTc), with a size between 10 and 90 microns in diameter. 99mTc is a gamma emitting radioactive isotope commonly used for diagnostic localization studies. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet Bell, Director, Clinical Research Operations | Sirtex Medical | 978-866-1798 | jbell@sirtex.com |
Not provided
| 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 | Mar 1, 2023 | Jan 8, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
Not provided
Not provided
| ID | Term |
|---|---|
| D013668 | Technetium Tc 99m Aggregated Albumin |
| ID | Term |
|---|---|
| D015609 | Organotechnetium Compounds |
| D009942 | Organometallic Compounds |
| D009930 | Organic Chemicals |
| D000418 | Albumins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 26434964 | Background | McCollough CH, Bushberg JT, Fletcher JG, Eckel LJ. Answers to Common Questions About the Use and Safety of CT Scans. Mayo Clin Proc. 2015 Oct;90(10):1380-92. doi: 10.1016/j.mayocp.2015.07.011. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Mean Absorbed Dose (Gy) for Critical Non-liver Organs | Posted | Mean | Standard Deviation | mGy | 18-24 hours |
|
|
|
| Primary | Mean Activity (Bq) for the Whole Body | Posted | Mean | Standard Deviation | GBq | 18-24 hours |
|
|
|
| Primary | Mean Activity (Bq) for Critical Non-liver Organs | Posted | Mean | Standard Deviation | GBq | 18-24 hours |
|
|
|
| Primary | Effective Dose (Gy) for the Whole Body | Posted | Mean | Standard Deviation | mGy | 18-24 hours |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
Upon completion of the Study, Institution and Investigator may publish or present the Study Data subject to the following terms: a copy of any proposed publication or disclosure of the results of the Study will be given to the Sponsor for review at least thirty (30) days prior to the date of submission for publication (including abstracts) or of public disclosure.
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| Title | Measurements |
|---|---|
|
| Kidney |
|
| Lungs |
|
| Pancreas |
|
| Spleen |
|
| Stomach |
|
| Upper bowel |
|
| Title | Measurements |
|---|---|
|
| Kidney |
|
| Lungs |
|
| Pancreas |
|
| Spleen |
|
| Stomach |
|
| Upper bowel |
|