Меню
Набор по приглашению NCT06276764

The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)

— Наблюдательное IPMN, Pancreatic Pancreas Cancer Pancreatic Cyst

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: LINFU®.
Кому может быть актуально
Состояния в реестре: IPMN, Pancreatic, Pancreas Cancer, Pancreatic Cyst. Базовые параметры: 18 лет — 90 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

The LINFU® U.S. Registry for the Detection of Dysplasia and Pancreatic Ductal Adenocarcinoma (PDAC) in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)

Обзор

In this study, LINFU® will be evaluated in patients who have been identified with IPMN to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia). The study will also help determine if LINFU® results in earlier intervention, treatment and improvement in patient outcomes.

Подробное описание

Adenocyte has developed a proprietary pancreatic cancer detection method, LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) that increases the sensitivity of pancreatic juice cytology. LINFU® excitation of circulating microbubbles increases the exfoliation of pancreatic ductal cells. The sensitivity of cytological examination of the pancreatic fluid obtained by LINFU® can also be potentially enhanced by neural network-based computer-assisted analysis.

In this study, LINFU® will be evaluated in patients who have been identified with IPMN to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia) which are not identified with current diagnostic tests. In addition, patients identified with PDAC or precursor lesions only with LINFU® and not detected with other diagnostic tests will be followed long term to determine the progression rate of these tumors and whether LINFU® results in earlier intervention, treatment and improvement in patient outcomes

Вмешательства

  • Диагностический тест LINFU®
    Patients will undergo low intensity non-focused ultrasound excitation of the pancreas for a total of 15 minutes. A contrast agent will be administered IV at five minute intervals. The patient will then receive a dose of secretin and the the patient's pancreatic juice will then be collected for a total of 15 minutes.

Первичные конечные точки

  • The number of pancreatic ductal adenocarcinomas or their precursor lesions, dysplasia, identified only with LINFU® will be compared to standard screening methods [Срок оценки: 5 years]
Вторичные конечные точки (2)
  • The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be determined over a 5 year period [Срок оценки: 5 years]
  • Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® that require medical or surgical intervention. [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • Both males and females will be enrolled and must be at least 18 years of age and under age of 90
  • Patients with a documented history of IPMN by any imaging method.
  • All patients must undergo contemporaneous imaging (within 90 days before or after the LINFU® procedure) with one or more of the following: EUS, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT
  • Patients undergoing EUS-FNA may be enrolled but the FNA must be performed after the LINFU® procedure
  • Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.

Критерии исключения

  • Patient under the age of 18 and over the age 90
  • Contraindications to LINFU® as determined by study investigators:
  • Patient with uncorrectable coagulopathy
  • Patient that cannot undergo anesthesia due to cardiopulmonary contraindication as deemed by the anesthesiologist
  • Unstable medically (cardiopulmonary, neurologic, or cardiovascular status)
  • Patients with IPMN that has been subjected to FNA or biopsy prior to the LINFU procedure
  • Patients with pancreatic cystic neoplasms other than IPMN i.e. mucinous cystic neoplasms, serous cystic neoplasms and other rare cystic lesions
  • Pregnant females will be excluded
  • Patient that is unable to provide informed consent
  • Patient with known allergy to the microbubble contrast agent or secretin

Study Design Overview:

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Manhattan Endoscopy Center — New York

Идентификаторы

NCT: NCT06276764 · Adenocyte 103

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗