Идёт набор NCT07478523

FAPI-PET Value for the Initial Screening of Pancreatic and Biliary Cancers

Фаза II С лечением Cholangiocarcinoma Pancreatic Adenocarcinoma

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: TEP-TDM au 68Ga-FAPI-46.
Кому может быть актуально: Состояния в реестре: Cholangiocarcinoma, Pancreatic Adenocarcinoma. Базовые параметры: от 18 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: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Diagnostic Value of 68Ga-FAPI-46 PET/CT in the Initial Work-up of Pancreatic and Biliary Cancers Eligible to a Curative Treatment

Обзор

Pancreatic cancer is one of the worst-prognosed cancers with a 5-year survival rate of less than 10%. Its incidence has been steadily increasing for several years in France and worldwide. Pancreatic adenocarcinoma may become the second leading cause of cancer mortality in the years 2030-2040. Current standard of care for pancreatic cancer imaging at initial workup comprise CT imaging and MRI. However, these imaging modalities lack sensitivity and accuracy, with an estimated rate of about 30% of patients either with visceral or lymph node metastasis discovered during planned surgery or with relapse occurring during the first 6 months after surgery suggesting occult metastasis at diagnosis. Therefore, there is a clear need for new imaging modalities at initial diagnosis for more adapted and individualized therapeutic decision. Cholangiocarcinoma (or cancer of the bile ducts) also has a dismal prognosis with a 5-year survival rate of 7%. The therapeutic objective is to obtain a surgical resection R0 when possible which can be associated with improved survival of up to 40% in appropriately selected patients. However, surgical morbidity and mortality are high, especially in peri-hilar forms. The detection of lymph node metastasis beyond the hepatic hilum is crucial, as surgery is considered futile in this situation. Current standard imaging at initial work-up include CT and MRI that have limited performance in estimating surgical resecability with a sensitivity of 60% for detecting lymph nodes metastasis and 67% for detecting distant metastasis. Therefore, there is also here an unmet need for improved baseline imaging. In summary, this project is focused on two digestive cancers with poor prognosis in which preoperative imaging accuracy remains today imperfect. Therefore, we aim to demonstrate, when compared with current standard imaging, that 68Ga-FAPI-46 PET/CT performed at baseline imaging in pancreatic and biliary duct cancers, leads to a change in TNM classification and subsequently to a change in therapeutic management. To our knowledge, this will be the first (or one of the first) structured multicenter prospective study to evaluate the additional and potentially decisive contribution of 68Ga-FAPI-46 PET/CT carried out after a standard imaging workup at initial diagnosis of pancreatic and biliary duct cancers. If the diagnostic superiority of 68Ga-FAPI-46 PET/CT is confirmed, this study could lead to define a new standard of care for the imaging of these cancers with poor prognosis. The study should also help to set the ground for future theranostic approaches where 68Ga-FAPI-46 PET/CT would help select patients for targeted radionuclide therapy.

Вмешательства

Препарат TEP-TDM au 68Ga-FAPI-46
PET-CT examination with 68Ga-FAPI-46 in the nuclear medicine department. 68Ga-FAPI-46 is administered intravenously at a mean activity of 2 MBq/kg

Первичные конечные точки

Proportion [Срок оценки: Inclusion (Day 0)]

Вторичные конечные точки (5)

Proportion of appropriate change of the M status of the TNM [Срок оценки: Inclusion (Day 0)]
Proportion of appropriate addition or removal of therapeutic management [Срок оценки: Inclusion (Day 0)]
Average number of tumor lesions, lymph node or distant [Срок оценки: Inclusion (Day 0)]
Cohen's kappa coefficient [Срок оценки: Inclusion (Day 0)]
Predictive values [Срок оценки: Inclusion (Day 0)]

Критерии участия

Критерии включения

Population 1: De novo pancreatic adenocarcinoma (pathological evidence) or strong suspicion of de novo pancreatic adenocarcinoma on imaging, immediately resectable, borderline or locally advanced, potentially requiring curative treatment and non-metastatic (M0), according to reference staging. - Population 2: De novo cholangiocarcinoma eligible for curative treatment (pathological evidence) or strong suspicion of de novo pancreatic adenocarcinoma on imaging, non-metastatic (M0), according to reference extension assessment. according to reference extension report

Criteria common to both populations:

Age >18 years at the time of signing the informed consent
Patient affiliated to a social security system
Free and informed consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research)