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qDSA Blood Flow Measurement in Patients Undergoing TAE of the Liver

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status

Enrolling

Conditions

Transarterial Embolism
Transarterial Chemoembolization

Treatments

Device: qDSA Blood Flow Measurement

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06971991
A539300 (Other Identifier)
Protocol Version: 4/18/24 (Other Identifier)
2024-1159

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Participants Undergoing TAE of the Liver
Experimental group
Treatment:
Device: qDSA Blood Flow Measurement

Trial contacts and locations

1

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Central trial contact

Radiology Coordinators

Data sourced from clinicaltrials.gov

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