qDSA Blood Flow Measurement in Patients Undergoing TAE of the Liver
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Give voluntary, written informed consent to participate in this study and willing to comply with study-related evaluation and procedure schedule
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
qDSA Blood Flow Measurement
DevicePre-, 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)
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Participants Undergoing TAE of the LiverExperimental treatment 1 intervention
Trial outcomes
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
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.
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)2
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.
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
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.
Time frame
measured during transarterial embolism (up to 1 hour), qDSA data processed retrospectively when data collection is complete (up to 6 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
Siemens Medical Solutions
Collaborator
Source ClinicalTrials.gov