Cutting Edge Imaging With PET-FAPI for Earlier Pancreatic Cancer Diagnosis (INDIGO-FAPI)
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: 68Ga-FAPI-46 for PET / CT scan.
- Кому может быть актуально
- Состояния в реестре: Pancreatic Ductal Adenocarcinoma (PDAC). 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
Cutting Edge Imaging for Earlier Pancreatic Cancer Diagnosis: Evaluation of Positron Emission Tomography (PET) With the Fibroblast Activation Protein Inhibitor (FAPI)
Обзор
Assessment of the relevance of a new medical imaging test, FAPI PET, which could detect progression or relapse earlier than other tests currently available. Ultimately, it could enable early forms of pancreatic cancer to be detected and used for screening. In addition to the usual examinations prescribed, FAPI PET scans will be repeated at several points in the treatment process. All study patients must first have been included in the Homing cohort (NCT 04363983, APHP promotion). Clinical characteristics, judgement criteria and results of biological or imaging examinations carried out as part of this cohort will be shared. Patient follow-up and participation in the study ends when conventional imaging (CT and MRI) shows disease progression, relapse or death.
Подробное описание
Development of imaging biomarkers derived from FAPI PET among patients with a newly-diagnosed resectable or locally advanced PDAC, in order (i) to detect a metastatic disease at inclusion and (ii) to detect disease recurrence after surgical resection with a higher sensitivity than the standard evaluation.
Prospective cohort involving repeated medical imaging with a new radiotracer (FAPI). Patients meeting inclusion criteria will be stratified according to the disease staging: resectable, borderline or locally advanced PDAC.
At inclusion after confirmed non-metastatic PDAC diagnosis, all patients will have:
Baseline exams (V1) with 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT (within 1 month after inclusion in HoMING study) for all enrolled patients with resectable, borderline or locally advanced PDAC at inclusion.
Second pre-operative exams (V1b) with 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT exams only for patients who received neoadjuvant/induction treatment.
Post-operative/Follow-up exams (V2 to Vn) with 68Ga-FAPI-46 PET/CT starting 2 months after surgery (with or without neoadjuvant/induction treatment) or following the neoadjuvant/induction treatment even if the patient is eventually not eligible for surgery (+/-1 month), and then every 3 months (+/-1 month).
All patients of this study must have been previously enrolled in the HoMING cohort (NCT 04363983, sponsor APHP). Endpoints and clinical characteristics, as well as results of other biological or imaging exams (MRI, spectral and conventional CT), will be shared with the HoMING cohort.
The follow-up ends as soon as conventional CT images show a disease progression/recurrence.
Investigators and patients will be blinded for the results of FAPI. Patients will be followed-up according to the care schedule with no modification of patient management. When disease progression/recurrence is diagnosed by conventional CT scan (gold standard), FAPI PET imaging at earlier time points (t -3 months, -6 months…) will be post-hoc reviewed to see whether small lesions could have been detected.
Вмешательства
- Препарат 68Ga-FAPI-46 for PET / CT scan
Gallium 68-labeled fibroblast activation protein inhibitor (FAPI) used as radiotracer during PET imaging.
Первичные конечные точки
- EFS: Event Free Survival [Срок оценки: 12 months]
Вторичные конечные точки (2)
- Adverse Event during 68Ga-FAPI-46 PET/CT exams [Срок оценки: 12 months]
- Evaluation of the tumor burden 68Ga-FAPI-46 PET/CT versus 18F-FDG PET/CT [Срок оценки: 12 months]
Критерии участия
Критерии включения
- Cyto/histologically proven PDAC
- Non-metastatic proven PDAC on recent (< 1 month) CT-scan and MRI
- Concomitant enrollment in the HoMING prospective cohort (Sponsor: AP-HP, NCT04363983)
- Age > 18 years old
- Affiliation to a social security scheme
- Signed informed consent
Критерии исключения
- Protected adults (guardianship, curatorship or safeguarding justice)
- Pregnant or breastfeeding woman
- Women of childbearing potential not using one highly effective method of contraception
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
- Диагностика
Центры проведения
Франция · 1 центр
- Institut Curie -site Saint-Cloud — Saint-Cloud
Идентификаторы
NCT: NCT06659705 · IC 2023-02