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Идёт набор NCT06061874

Ga68-FAPI-46 PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis

Без фазы С лечением Cancer Peritoneal Carcinomatosis

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: FAPI PET/CT.
Кому может быть актуально
Состояния в реестре: Cancer, Peritoneal Carcinomatosis. 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
Бельгия
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

Ga68-labeled Fibroblast Activation Protein Inhibitor-46 (Ga68-FAPI-46) PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis

Обзор

This is a prospective, phase II, non-randomized clinical imaging trial. Ga68-FAPI-46 is a novel radiotracer used in PET/CT imaging, targeting a protein of the tumor microenvironment called FAP (Fibroblast activation protein). The aim of the study is to assess the accuracy of Ga68-FAPI-46 PET/CT for preoperative assessment of peritoneal carcinomatosis in colorectal and ovarian cancer.

Подробное описание

Fibroblast activation protein (FAP) is a type II transmembrane glycoprotein expressed on the surface of cancer-associated fibroblasts (CAFs) in the stroma of various tumor entities. Recently, radiolabeled molecules targeting the FAP, called FAP inhibitors (FAPI) labelled with Gallium-68, have been developed for molecular imaging with PET/CT (positron emission tomography/computed tomography). This radiotracer often presents a higher cancer lesion detectability than F18-FDG (fluorodeoxyglucose), partly thanks to its higher tumour-to-background ratio achieved by a low background activity, particularly in the brain, abdominal cavity and liver. These advantages have resulted in a superior sensitivity of Ga68-FAPI PET/CT over F18-FDG and higher SUV (standardized uptake value) in evaluating various types of cancer. In this context, Ga68-FAPI PET/CT seems promising to further study as a clinical imaging modality for preoperative assessment of peritoneal carcinomatosis.

In this study, the investigators correlate Ga68-FAPI PET/CT findings in terms of peritoneal involvement with intraoperative findings based on histopathology and try to find out how accurate Ga68-FAPI PET/CT is for the preoperative assessment of peritoneal carcinomatosis.

Вмешательства

  • Диагностический тест FAPI PET/CT
    The radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is applied intravenously for molecular imaging of FAP expression with FAPI PET/CT.

Первичные конечные точки

  • Correlation of the Ga68-FAPI PET/CT derived PCI (peritoneal cancer index) score with the intraoperative PCI based on histopathology of resected specimen (the reference standard) [Срок оценки: Through completion of post-surgical pathological examination, up to 2 years since the study initiation]
Вторичные конечные точки (2)
  • Comparison of PCI obtained with Ga68-FAPI PET/CT to the PCI calculated on standard preoperative imaging. [Срок оценки: Through completion of imaging examinations, up to 2 years since the study initiation]
  • Assessment of the impact of neoadjuvant chemotherapy on the FAPI expression of target lesions at baseline. [Срок оценки: Through completion of post-neoadjuvant chemotherapy FAPI PET examination,up to 2 years since the study initiation]

Критерии участия

Критерии включения

  • Histologically proven colorectal and ovarian cancer.
  • Known or suspected peritoneal metastases from the tumour of origin.
  • Scheduled for peritoneal complete cytoreductive surgery with curative intent with or without neoadjuvant chemotherapy.
  • ECOG (Eastern Cooperative Oncology Group) Performance status ≤2.
  • Signed written informed consent obtained before any study-specific screening procedures.

Критерии исключения

  • Non-resectable extra-abdominal metastasis and/or >3 hepatic metastases on standard work-up
  • Known chronic inflammatory conditions including the intestinal system (eg. inflammatory bowel disease, Crohn's disease)
  • Pregnant and lactating women
  • Previous or concurrent malignancy diagnosed within the last 3 years except adequately treated in situ carcinoma of the cervix uteri and basal or squamous cell skin cancer.
  • Subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.

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

Бельгия · 1 центр
  • Institut Jules Bordet — Brussels

Идентификаторы

NCT: NCT06061874 · IJB-NM-FAPeCa1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗