Transarterial EmbolismNCT06971991
qDSA Blood Flow Measurement in Patients Undergoing TAE of the Liver
A study testing qDSA Blood Flow Measurement in people with Transarterial Embolism and Transarterial Chemoembolization, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transarterial Embolism, Transarterial Chemoembolization, Radioembolization
- What is being tested?
- qDSA Blood Flow Measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Give voluntary, written informed consent to participate in this study and willing to comply with study-related evaluation and procedure schedule
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UW Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: qDSA Blood Flow Measurement in Patients Undergoing Transarterial Embolization (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.
- Being tested
- qDSA Blood Flow Measurement
- Keywords
- Quantitative digital subtraction angiography (qDSA), Radioembolization, TAE, TACE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qDSA Blood Flow MeasurementDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Participants Undergoing TAE of the Liver | Experimental | Not described Receives: Device: qDSA Blood Flow Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients in which qDSA measurements demonstrate successive reductions in hepatic arterial velocity at the pre-, mid-, and post-embolization time points
Measured: 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
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.
Measured: 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
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.
Measured: 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: measured during transarterial embolism (up to 1 hour), qDSA data processed retrospectively when data collection is complete (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start13 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transarterial EmbolismStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Medical Solutions
- Responsible party
- Sponsor
- Investigators
- Paul Laeseke, MD, PhD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971991
- Sponsor's protocol ID
- 2024-1159
- Other IDs
- A539300, Protocol Version: 2/10/26
- Status last verified
- Sep 2026
- First submitted
- 6 May 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- qDSA Blood Flow Measurement in Patients Undergoing Transarterial Embolization (TAE) of the Liver
- ClinicalTrials.gov ID
- NCT06971991
- Acronym / sponsor ID
- 2024-1159
- Keywords
- Quantitative digital subtraction angiography (qDSA), Radioembolization, TAE, TACE
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Siemens Medical Solutions
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Undergoing TAE of the Liver | Experimental | Device: qDSA Blood Flow Measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Give voluntary, written informed consent to participate in this study and willing to comply with study-related evaluation and procedure schedule
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qDSA Blood Flow MeasurementPre-, 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) | Device | Participants Undergoing TAE of the Liver |
Primary outcome
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)
3 secondary outcomes
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Laeseke, MD, PhD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing qDSA Blood Flow Measurement in people with Transarterial Embolism and Transarterial Chemoembolization, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radiology Coordinators (608-282-8349, Radstudy@uwhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.