Breast Cancer PET/CT Imaging With 68Ga-pAKTi
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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: 68Ga-pAKTi PET/CT probe.
- Кому может быть актуально
- Состояния в реестре: Breast Cancers, PIK3CA Mutation-Related Tumors, PI3K Pathway Activated Tumors, PET / CT. Базовые параметры: от 18 лет · Женщины.
- 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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Официальное название
68Ga-Labeled pAKTi Molecular Probe Combined With PET/CT for Breast Cancer Imaging
Обзор
Abnormal activation of the PI3K-AKT signaling pathway in breast cancer patients is closely associated with tumor progression. Phosphorylated AKT (p-AKT) serves as a key indicator of pathway activation. In this study, we utilize a novel probe, 68Ga-pAKTi, which enables precise targeting of tumor p-AKT expression levels to monitor PI3K-AKT pathway activation. The aim of this study is to evaluate the diagnostic accuracy of 68Ga-pAKTi PET/CT in detecting p-AKT expression in breast cancer and to compare its performance with that of 18F-FDG PET/CT. A total of 20 patients with breast cancer will be enrolled. Screening will be conducted within 14 days prior to administration of 68Ga-pAKTi (from Day -14 to Day -1). Subjects who meet all inclusion criteria and none of the exclusion criteria will receive an intravenous injection of 68Ga-pAKTi on Day 0, followed by PET/CT imaging. Biopsy/pathological results and conventional imaging findings will be followed up to validate the diagnostic efficacy of 68Ga-pAKTi PET/CT in accurately detecting p-AKT expression in breast cancer.
Вмешательства
- Диагностический тест 68Ga-pAKTi PET/CT probe
A total of 20 patients with breast cancer will be enrolled. Screening will be conducted within 14 days prior to administration of 68Ga-pAKTi (from Day -14 to Day -1). Subjects who meet all inclusion criteria and none of the exclusion criteria will receive an intravenous injection of 68Ga-pAKTi on Day 0, followed by PET/CT imaging.
Первичные конечные точки
- Standard uptake value [Срок оценки: From enrollment to the end of imaging at 2 weeks]
Критерии участия
Критерии включения
- Voluntarily signs the informed consent form.
- Age ≥ 18 years.
- Pathologically confirmed or highly suspected breast cancer based on conventional imaging.
- Estimated life expectancy > 3 months as determined by the physician.
- Agrees to practice strict contraception for at least 28 days following the PET/CT examination.
- Willing and able to comply with the study protocol.
- Has not undergone surgical resection of the lesion.
- Has participated in molecular testing at the Precision Oncology Center of Fudan University Shanghai Cancer Center, and harbors a PIK3CA mutation, PTEN mutation, or upregulation of the PI3K-AKT-mTOR pathway.
Критерии исключения
- Pregnant or breastfeeding women.
- Unable to lie still on the PET/CT scanner bed during the examination or intolerant to PET imaging.
- Participation in another interventional clinical trial within 1 month prior to screening.
- Patients who are lost to follow-up.
- Any other condition that, in the opinion of the investigator, may interfere with the study or make the subject unsuitable for participation.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Fudan University Shanghai Cancer Center — Шанхай
Идентификаторы
NCT: NCT06943313 · 2503317-27