qDSA Blood Flow Measurement in Patients Undergoing TAE of the Liver

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-13

Study Completion Date

2026-03-31

Brief Summary

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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 transarterial 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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Detailed Description

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Conditions

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Transarterial Embolism Transarterial Chemoembolization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Participants Undergoing TAE of the Liver

Group Type EXPERIMENTAL

qDSA Blood Flow Measurement

Intervention Type DEVICE

The research intervention is limited to several additional qDSA image acquisitions, which include administration of additional iodinated contrast medium.

Interventions

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qDSA Blood Flow Measurement

The research intervention is limited to several additional qDSA image acquisitions, which include administration of additional iodinated contrast medium.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No