qDSA Blood Flow Measurement in Patients Undergoing TAE of the Liver

N/ARecruitingNCT06971991

University of Wisconsin, Madison20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Transarterial Embolism Transarterial Chemoembolization Radioembolization

Interventions

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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)

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)

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)

qDSA Blood Flow Measurement in Patients Undergoing TAE of the Liver

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts