qDSA Blood Flow Measurement in Patients Undergoing TAE of the Liver

NCT06971991 | Recruiting FDA Device

• 3 other identifiers: 2024-1159A539300Protocol Version: 2/10/26
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Radioembolization; Transarterial Embolism; Transarterial Chemoembolization

Keywords

Quantitative digital subtraction angiography (qDSA); Radioembolization; TAE; TACE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (1)

Participants Undergoing TAE of the Liver

EXPERIMENTAL

Device: qDSA Blood Flow Measurement

Interventions

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)

Participants Undergoing TAE of the Liver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Give voluntary, written informed consent to participate in this study and willing to comply with study-related evaluation and procedure schedule

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Siemens Medical Solutions: collaborator

Study Sites (1)

UW Hospital and Clinics

Madison, Wisconsin, 53792, United States

RECRUITING

Study Officials

• Paul Laeseke, MD, PhD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radiology Coordinators

CONTACT

608-282-8349; Radstudy@uwhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: March 13, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)