Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 18F-EF5 maximum standardized uptake values (SUVmax)
研究概览
简要总结
The goal of this non-randomized prospective study is to use 18F-EF5-PET/CT imaging to identify and locate intraabdominal hypoxic ovarian cancer lesions. With targeted surgical sampling, precisely obtain hypoxic and potentially chemoresistant cancer tissue for our analyses and identify key molecular differences between hypoxic and non-hypoxic tumors within the same patient.
A portion of advanced stage EOC are inoperable at diagnosis and can be treated with neoadjuvant chemotherapy (NACT) before surgery. This approach offers a unique opportunity to study how hypoxic tumor areas respond to treatment.
详细描述
MORE SPECIFIC AIMS
- To validate the feasibility of PET-tracer EF5 in EOC imaging.
- Quantify the amount and exact locations of hypoxic tumors in EOC patients using herein developed protocol and tracers (18F-EF5 and 18F-FDG) in diagnostic and neoadjuvant settings.
- Measure the non-cancer related EF5 accumulation spots and establish the potential pitfalls in abdominal EF5 imaging
- Establish a method to verify hypoxic locations with 18F-EF5-PET/CT information during the operation.
- Develop and validate a model that predicts chemotherapy response based on functional imaging information.
- To reveal hypoxia related alterations in collected tissue samples (i.e. altered DNA damage repair, altered mitochondrial respiratory functioning, overexpression of hypoxia response elements etc)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed advanced epithelial ovarian, primary peritoneal or fallopian tube cancer.
- •age 18-79 years
- •informed concent
排除标准
- •previous cancer
- •pregnancy or nursing
研究组 & 干预措施
PDS
18F-EF5 PET/CT and 18F-FDG PET/CT scan prior to primary cytoreductive surgery and targeted sample collection during primary cytoreductive surgery
干预措施: Imaging with 18F-EF5 PET/CT (Device)
IDS
18F-EF5 PET/CT and 18F-FDG PET/CT scans prior to diagnostic laparoscopy and after neoadjuvant chemotherapy before interval cytoreductive surgery .
Targeted sample collection during diagnostic laparoscopy and interval cytoreductive surgery
干预措施: Imaging with 18F-EF5 PET/CT (Device)
结局指标
主要结局
18F-EF5 maximum standardized uptake values (SUVmax)
时间窗: 2-3 years
Tumor and musculus gluteus maximus SUVmax ratio ≥1.5 is considered to refer to hypoxia
次要结局
- Disease-free survival(5 years)
- Correlation between the uptake of 18F-EF5 isotope in PET/CT and immunohistochemical profile of tumor tissue(2-3 years)
- Overall survival(5 years)