Radioembolization, Transarterial Chemoembolization, Transarterial Embolism
Conditions
Keywords
Quantitative digital subtraction angiography (qDSA), Radioembolization, TAE, TACE
Brief summary
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.
Interventions
DEVICEqDSA Blood Flow Measurement
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)
Sponsors
University of Wisconsin, Madison
Siemens Medical Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Give voluntary, written informed consent to participate in this study and willing to comply with study-related evaluation and procedure schedule
Exclusion criteria
* Pregnancy or breastfeeding * Patients with an acute kidney injury or stage IV or V chronic kidney disease (Cr greater than 2.4 or estimated glomerular filtration rate (eGFR) less than 30), unless anuric and on dialysis without expected return of renal function. * Patients with an iodinated contrast allergy who cannot be adequately premedicated to receive contrast as part of the embolization procedure. * Patients with a physical or psychological condition that would impair study participation. * The patient is judged unsuitable for study participation by the Investigator for any other reason
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of flow reductions using qDSA compared with conventional DSA (current clinical standard): Percent Flow reduction from 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) | 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. |
| Assessment of flow reductions using qDSA compared with conventional DSA (current clinical standard): Number of procedures retrospectively judged to end early | 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) | 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. |
| Velocity measurements made on qDSA vs transabdominal Doppler US | measured during transarterial embolism (up to 1 hour), qDSA data processed retrospectively when data collection is complete (up to 6 months) | qDSA results (relative velocity drop as well as absolute velocities when possible) will be compared to transabdominal ultrasound measurements acquired during the procedure. |
Countries
United States
Contacts
CONTACTRadiology Coordinators
PRINCIPAL_INVESTIGATORPaul Laeseke, MD, PhD
UW School of Medicine and Public Health
Outcome results
None listed