Clinical Application of 68Ga-FL-031 PET in the Diagnosis and Staging of Malignant Tumors
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Injection of 68Ga-FL-031, Injection of 18F-FDG.
- Кому может быть актуально
- Состояния в реестре: Malignant Tumors, SSTR2, PET. 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
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The project's objective is to recruit patients with clinically confirmed or suspected small cell lung cancer, breast cancer, nasopharyngeal carcinoma and other tumours for 68Ga-FL-031 PET imaging and 18F-FDG PET imaging. The histopathology of biopsy or surgical specimens was taken as the final diagnostic criteria, and the presence or absence of tumour lesions was confirmed by the aforementioned imaging. The location and nature of the lesion, and the presence or absence of metastasis, were then judged. The objective was to analyse and clarify the diagnostic efficacy of 68Ga-FL-031 PET imaging for the aforementioned malignant tumours. The objective of this study is to analyse the correlation between the 68Ga-FL-031 PET imaging tumour tissue uptake value and the tumour tissue immunohistochemical staining SSTR2 target expression.
Вмешательства
- Препарат Injection of 68Ga-FL-031
Patients will be injected with 68Ga-FL-031and PET imaging was performed at different time points - Препарат Injection of 18F-FDG
Patients will be injected with 18F-FDG and PET imaging was performed
Первичные конечные точки
- Visual and standardized uptake values assessment of lesions and biodistribution [Срок оценки: 1 year]
Вторичные конечные точки (1)
- Pathological sections of tumour tissue [Срок оценки: 1 year]
Критерии участия
Критерии включения
- The subject or their legal representative is permitted to sign the informed consent form.
- The subject has committed themselves to adherence to the prescribed research procedures and to cooperation in the implementation of the entire study process.
- Adult patients (aged 18 years or older), irrespective of gender
- Patients with a clinical suspicion or confirmed diagnosis of small cell lung cancer, breast cancer, nasopharyngeal carcinoma, and other tumours (for which supporting evidence is provided in the form of serum-related tumour markers, ultrasound, CT, MRI and other image data, and histopathological examination)
- The patient is generally in good condition
- It is mutually agreed upon by all parties involved that the designated specimen shall be utilised for the purposes of this study.
Критерии исключения
- The patient or his legal representative is unable or unwilling to sign the informed consent
- The patient is unable to cooperate with the implementation of the whole process research
- The patient has been diagnosed with acute systemic diseases and electrolyte disorders
- Pregnant women or lactating women, etc
- In the event of other circumstances being deemed by the investigator to be unsuitable for participation in the study, such patients must be excluded on the basis of their known intolerance to SSTR2 targeted substances.
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
Китай · 1 центр
- Wuhan Union Hospital — Ухань
Идентификаторы
NCT: NCT07301801 · XLan-0603