Clinical Study of 68Ga-labeled Novel Nectin-4 Bicyclic Peptide PET/CT for Imaging of Solid Tumors With High Nectin-4 Expression
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: Immunohistochemistry.
- Кому может быть актуально
- Состояния в реестре: Solid Tumors With High Expression of Nectin4. 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
Tumors are one of the major diseases threatening human health, among which solid tumors account for a considerable proportion. Nectin-4, as an important cell adhesion molecule, shows a highly expressed state in various solid tumors. In triple-negative breast cancer, the high expression rate of Nectin-4 can reach more than 50%, and it is closely associated with tumor invasion, metastasis and poor prognosis. Relevant studies have shown that the five-year survival rate of triple-negative breast cancer patients with high expression of Nectin-4 is significantly lower than that of patients with low expression. In urothelial carcinoma, the positive expression rate of Nectin-4 is also relatively high, reaching 40%-60%, and it is a highly potential target for tumor treatment and diagnosis. Its abnormal expression in solid tumors has opened up a new direction for the early diagnosis and targeted therapy of tumors. However, at present, the precise diagnosis and effective treatment of solid tumors with high expression of Nectin-4 still face many challenges. There is an urgent need for new technologies and methods to improve the diagnosis and treatment level in order to improve the prognosis of patients. Therefore, this study aims to develop a method targeting the Nectin4 bicyclic peptide to achieve non-invasive visualization of Nectin4 expression in tumors. This approach may also contribute to the formulation and optimization of clinical treatment strategies
Вмешательства
- Диагностический тест Immunohistochemistry
Nectin4 Immunohistochemistry testing
Первичные конечные точки
- PET/CT imaging SuV value [Срок оценки: 0-45 minutes, 60 minutes]
Критерии участия
Критерии включения
- 1\. Age: 18 to 75 years old (including the boundary value), gender not limited. 2. Solid tumors (such as urothelial carcinoma, breast cancer, lung cancer, etc.) that have been pathologically diagnosed with high expression of Nectin-4 within one month before imaging.
3\. At least one evaluable tumor lesion (primary or metastatic) exists. 4. Voluntarily sign the informed consent form and be able to cooperate with the research process.
5.ECOG score: 0 to 2 points, expected survival period: ≥6 months.
Критерии исключения
- 1\. Combined with other active malignant tumors (excluding non-melanoma skin cancer or carcinoma in situ).
2\. Severe heart, liver and kidney insufficiency (such as ALT/AST >3 times ULN, creatinine clearance rate <30 mL/min).
3\. Uncontrolled systemic infections or immune system diseases. 4. Pregnant or lactating women, or patients of childbearing age who have not taken effective contraceptive measures.
5\. Previously received Nectin-4 targeted therapy (such as Enfortumab vedotin).
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
- The First Affiliated Hospital of Soochow University — Сучжоу
Идентификаторы
NCT: NCT07319130 · 2025-68Ga-Nectin-4-peptide 02