68Ga-Labeled pAKTi Molecular Probe Combined With PET/CT for Breast Cancer Imaging
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Standard uptake value
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Standard uptake value
时间窗: From enrollment to the end of imaging at 2 weeks
次要结局
未报告次要终点
研究者
Shaoli Song, PhD
Professor
Fudan University