Diagnosis of Metastatic Tumors on 68Ga-FAPI PET-CT and Radioligand Therapy with 177Lu-EB-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 for PET / CT scan and 177Lu-EB-FAPI for therapy.
- Кому может быть актуально
- Состояния в реестре: 177Lu-EB-FAPI. Базовые параметры: 18 лет — 80 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
FAP is a fibroblast activation protein and overexpressed in many tumor tissues. This study is intended to conduct preliminary clinical transformation and internal irradiation dosimetry research on 177Lu-EB-FAPI--a new 177Lu therapeutic drug modified by Evans Blue (EB) for the first time in the world.
Подробное описание
Fibroblast activation protein (FAP) is a serine peptidase on the surface of tumor associated fibroblasts. It belongs to type II transmembrane glycoprotein. It is rich and characteristic expressed in tumor associated fibroblasts. It has special biological characteristics and stable genome. FAP is expressed at a high level in mesenchymal cells during the embryonic period and is inhibited shortly after birth. It is usually not expressed or expressed at a low level in the resting tissues of normal adults, but it is highly expressed in diseases related to tissue repair and matrix reconstruction, such as wound healing, inflammatory response, fibrosis and cancer It plays an important role in metastasis and immunosuppression.Currently, 68Ga labeled FAPI (68Ga-FAPI) has been successfully applied to a variety of tumor PET/CT imaging, including lung cancer, breast cancer, and gastrointestinal tract tumors.By modifying FAPI with Evans blue (EB) to form a new EB-FAPI, endogenous albumin can be used as a reversible carrier to prolong the retention time of drugs in the blood, thus increasing the targeted aggregation and retention of 177Lu-EB-FAPI in tumor cells, and effectively killing a variety of transplanted tumors with positive FAP expression.we'll try to assess the safety and therapeutic response to 177Lu-EB-FAPI in patients with metastatic tumors in human.
Вмешательства
- Препарат 68Ga-FAPI for PET / CT scan and 177Lu-EB-FAPI for therapy
Patients with positive results were screened with 68Ga-FAPI PET / CT, and 2.22GBq(60mci) 177Lu-EB-FAPI was injected intravenously for therapy after contraindications were excluded and informed consent was signed.
Первичные конечные точки
- Safety of therapy [Срок оценки: through study completion, an average of 1 year]
- Therapeutic effect [Срок оценки: through study completion, an average of 1 year]
Вторичные конечные точки (1)
- Diagnostic value [Срок оценки: through study completion, an average of 1 year]
Критерии участия
Критерии включения
- confirmed treated or untreated metastatic tumors patients;
- 68Ga-FAPI PET/CT and 18F-FDG PET/CT within two weeks;
- signed written consent.
Критерии исключения
- pregnancy;
- breastfeeding;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance
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
- Лечение
Центры проведения
Китай · 1 центр
- Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union — Пекин
Идентификаторы
NCT: NCT05400967 · PekingUMCH-NMLUFAPI