Clinical trial NCT06971991: qDSA Blood Flow Measurement in Patients Undergoing TAE of the Liver
Official title: qDSA Blood Flow Measurement in Patients Undergoing Transarterial Embolization (TAE) of the Liver
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transarterial Embolism
Transarterial Chemoembolization
Keywords: Quantitative digital subtraction angiography (qDSA)
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Siemens Medical Solutions
First posted: 2025-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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 transarterial 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients in which qDSA measurements demonstrate successive reductions in hepatic arterial velocity at the pre-, mid-, and post-embolization time points
timeFrame: 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 outcomes:
measure: Assessment of flow reductions using qDSA compared with conventional DSA (current clinical standard): Percent Flow reduction from baseline
timeFrame: 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: Assessment of flow reductions using qDSA compared with conventional DSA (current clinical standard): Number of procedures retrospectively judged to end early
timeFrame: 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: Velocity measurements made on qDSA vs transabdominal Doppler US
timeFrame: measured during transarterial embolism (up to 1 hour), qDSA data processed retrospectively when data collection is complete (up to 6 months)
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Paul Laeseke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: