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| ID | Type | Description | Link |
|---|---|---|---|
| A539300 | Other Identifier | UW Madison | |
| Protocol Version: 2/10/26 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Siemens Medical Solutions | INDUSTRY |
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The purpose of this research is to evaluate a new technique, quantitative digital subtraction angiography (qDSA), to measure blood flow during liver embolization procedures. Liver embolization is a way of treating liver tumors by blocking blood flow to it. The qDSA technique could help doctors ensure the blood flow to the tumor is decreased by the right amount by calculating blood flow before, during, and after the procedure. Up to 20 participants will be enrolled for 1 study visit and data collection for up to 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Undergoing TAE of the Liver | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| qDSA Blood Flow Measurement | Device | Pre-, mid-, and post-embolization, qDSA and transabdominal US Doppler images will be acquired for research purposes during TAE and TACE procedures. For patients undergoing radioembolization, qDSA and US Doppler images will be acquired during both the preparatory angiogram and therapy angiogram (prior to delivery of the radioactive particles) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients in which qDSA measurements demonstrate successive reductions in hepatic arterial velocity at the pre-, mid-, and post-embolization time points | data collected pre-embolization, mid-embolization, and post-embolization (up to 1 hour), data processed retrospectively for this measure when data collection is complete (up to 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of flow reductions using qDSA compared with conventional DSA (current clinical standard): Percent Flow reduction from baseline | This will be done through a reader study where interventional radiologists will review conventional pre-, mid-, and post-embolization DSA sequences and asked to quantify the percent flow reduction relative to baseline. | data collected pre-embolization, mid-embolization, and post-embolization (up to 1 hour), data processed retrospectively for this measure when data collection is complete (up to 6 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Radiology Coordinators | Contact | 608-282-8349 | Radstudy@uwhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Paul Laeseke, MD, PhD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Hospital and Clinics | Recruiting | Madison | Wisconsin | 53792 | United States |
The study team will seek and IRB determination prior to any secondary uses of data in the future for research related to qDSA. A change of protocol will be submitted to the IRB to report any sharing of data to institutions other than the sponsor.
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| Assessment of flow reductions using qDSA compared with conventional DSA (current clinical standard): Number of procedures retrospectively judged to end early | This will be done through a reader study where interventional radiologists will review conventional pre-, mid-, and post-embolization DSA sequences and asked to judge whether the embolization procedure should proceed or end. | data collected pre-embolization, mid-embolization, and post-embolization (up to 1 hour), data processed retrospectively for this measure when data collection is complete (up to 6 months) |
| Velocity measurements made on qDSA vs transabdominal Doppler US | qDSA results (relative velocity drop as well as absolute velocities when possible) will be compared to transabdominal ultrasound measurements acquired during the procedure. | measured during transarterial embolism (up to 1 hour), qDSA data processed retrospectively when data collection is complete (up to 6 months) |