qDSA Blood Flow Measurement in Patients Undergoing TAE of the Liver

Официальное название

qDSA Blood Flow Measurement in Patients Undergoing Transarterial Embolization (TAE) of the Liver

Обзор

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.

Вмешательства

• Устройство qDSA Blood Flow Measurement
  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)

Первичные конечные точки

• Number of patients in which qDSA measurements demonstrate successive reductions in hepatic arterial velocity at the pre-, mid-, and post-embolization time points [Срок оценки: 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)]

Вторичные конечные точки (3)

• Assessment of flow reductions using qDSA compared with conventional DSA (current clinical standard): Percent Flow reduction from baseline [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: measured during transarterial embolism (up to 1 hour), qDSA data processed retrospectively when data collection is complete (up to 6 months)]

Критерии участия

Критерии включения

• Give voluntary, written informed consent to participate in this study and willing to comply with study-related evaluation and procedure schedule

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 1 центр

• UW Hospital and Clinics — Madison

Идентификаторы

NCT: NCT06971991 · 2024-1159 · A539300 · Protocol Version: 2/10/26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗