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NCT Number: NCT06971991

qDSA Blood Flow Measurement in Patients Undergoing TAE of the Liver

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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Key information

Conditions

Transarterial Embolism Radioembolization Transarterial Chemoembolization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UW Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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

    Time frame: 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

  1. Assessment of flow reductions using qDSA compared with conventional DSA (current clinical standard): Percent Flow reduction from baseline

    Time frame: 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.

  2. Assessment of flow reductions using qDSA compared with conventional DSA (current clinical standard): Number of procedures retrospectively judged to end early

    Time frame: 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.

  3. Velocity measurements made on qDSA vs transabdominal Doppler US

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Radiology Coordinators

CONTACT

[email protected]

608-282-8349

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Siemens Medical Solutions

Registry information

Official study title

qDSA Blood Flow Measurement in Patients Undergoing Transarterial Embolization (TAE) of the Liver

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 14, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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