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Идёт набор NCT07629609

BEFAST Study, [68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer

Фаза II С лечением Pancreatic Cancer, Adult Gastroesophageal Cancer (GC)

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]Ga-FAPI-46.
Кому может быть актуально
Состояния в реестре: Pancreatic Cancer, Adult, Gastroesophageal Cancer (GC). 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
Дания
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

[68Ga]Ga-FAPI Total Body PET/CT for Improving Diagnostic Sensitivity and Preoperative Staging in Gastroesophageal Cancer and Pancreatic Cancer

Обзор

The goal of this clinical trial is to learn if \[68Ga\]Ga-FAPI-46 Total Body PET/CT can diagnose patients suffering from gastroesophageal cancer and pancreatic cancer. The investigators hope that \[68Ga\]Ga-FAPI-46 Total Body PET/CT can improve staging and treatment evaluation for these patient groups. The main questions the trial aims to answer are: * Is \[68Ga\]Ga-FAPI-46 Total Body PET/CT better at diagnosing metastatic disease in the abdomen compared other imaging modalities? * Can \[68Ga\]Ga-FAPI-46 Total Body PET/CT produce accurate images in less than 30 min? Researchers will examine three different patient groups: Group A) patients with pancreatic cancer, who are referred to surgery. Group B1) patients with gastroesophageal cancer, who are referred to diagnostic surgery (laparoscopy). Group B2) a subgroup of gastroesophageal cancer patients, with a specific subtype cancer (signet ring cell carcinoma or poorly cohesive carcinoma), who are referred to oncological treatment. Participants will undergo: * One \[68Ga\]Ga-FAPI Total Body PET/CT before surgery (Group A), or before laparoscopy (group B1), or before oncological treatment (Group B2). * Participants in group B2 will also undergo a second \[68Ga\]Ga-FAPI-46 Total Body PET/CT during treatment with chemotherapy. * All participants will fill out one questionnaire. * Researchers will follow the patients after the scans for 1 year.

Вмешательства

  • Препарат [68Ga]Ga-FAPI-46
    PET/CT scan with the tracer \[68Ga\]Ga-FAPI-46

Первичные конечные точки

  • Sensitivity of [68Ga]Ga-FAPI-46 Total Body PET/CT [Срок оценки: From the time of scan to the end of follow up at 1 year]
Вторичные конечные точки (3)
  • Accuracy measurements of [68Ga]Ga-FAPI-46 Total Body PET/CT [Срок оценки: From the time of scan to the end of follow up at 1 year]
  • Estimated potential impact/change in patient management. [Срок оценки: From the time of scan to the end of follow up at 1 year]
  • Description of FAPI-uptake from lesions suspicious of malignancy. [Срок оценки: From the time of scan to the end of follow up at 1 year]

Критерии участия

Inclusion criteria for group A

  • Male or female, over 18 years old
  • Patients with suspected pancreatic cancer based on morphological findings on standard imaging
  • CT or MRI or \[18F\]FDG PET/CT evaluated on MDT with no initial sign of distant metastases
  • Subjects must have been considered suitable for curative surgery at the time of the referral
  • Subjects must be able to read and understand the patient information in Danish to give informed consent

Inclusion criteria for group B1

  • Male or female over 18 years old
  • Histological verified carcinoma from the lower esophagus, GEJ, or stomach
  • Subjects must be considered operable and resectable at the time of referral for MDT
  • Subjects must be able to read and understand the patient information in Danish to give informed consent

Inclusion criteria for group B2

  • Male or female over 18 years old
  • Histological verified SRCC or PCC from the lower esophagus, GEJ, or stomach
  • Subjects with localized disease assigned to perioperative chemotherapy or subjects with metastatic disease assigned to palliative systemic treatment.
  • Subjects must be able to read and understand the patient information in Danish to give informed consent

Критерии исключения

  • Pregnancy or lactation
  • Weight more than the maximum limit of a PET/CT-scanner bed (140 kg)
  • History of allergic reaction due to compounds similar to the chemical composition of \[68Ga\]Ga-FAPI-46

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

Дания · 1 центр
  • Rigshospitalet — Copenhagen

Идентификаторы

NCT: NCT07629609 · 523_22 · 2023-503632-41-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗