MISOBOLD - Prostate Cancer Hypoxia Using BOLD MRI and 18F-MISO PET Imagin
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- comparison between histological results and oxygenation quantitative values from MRI and PET exams
研究概览
简要总结
This feasibility exploratory study objective is to assess the ability of combined MRI BOLD and 18F-MISO PET imaging to visualize tumor hypoxia compare to histological results obtained after radical prostatectomy in order to, in time, be able to identify patient with bad prognostic and to offer them the best therapeutic strategy.
详细描述
Prostate cancer is the fisrt one in male with 80.000 new cases each year in France. Forty thousand curative treatments are performed each year, but 25 to 30% of these patients will present a cancer reccurence after radical surgery or conformationnal radiotherapy, Tissu hypoxia seems to be mainly responsible of the local reccurence and conduct to molecular damages that creates carcinogenesis and tumor agressitivity. This hypoxia inhibits the DNA healing and the apoptosis but increases the angiogenesis, that leads to treatment resistance. L. Marignol &al clearly showed that hypoxia may have a main role in hormonal resistance. Furthermore, M. Milosevic & al showed that hypoxia is an independent factor of local reccurence after radiotherapy. Nowadays, new technics of IMRT in radiotherapy planning could be able to target an hypoxic prostate region to prevent reccurence. Patients who are eligible to radical prostatectomy will benefit of a prostate MRI with BOLD sequences and a 18F-misonidazole PET before surgery. The results of these two technics will be compared to the histological results using CAIX and HIF immunohistochemistery markers
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient above
- •Prostate tumor with histological confirmed diagnosis and highly radiological suspected target on MRI
- •High risk patient : >T2c grade, Glasgow score > 7 and PSA > 20ng/ml
- •Surgical treatment chosen during multidisciplinary meeting
- •Patient must have undergone MRI with BOLD sequence less than 6 month prior surgery
- •Member or beneficiary of a social security system.
- •Signed informed consent.
排除标准
- •Patient included in another clinical study
- •Geographical, social or psychological reasons preventing patient from submitting to the study's medical monitoring
- •Patient deprive of liberty, adult subjects to legal protection or unable to give consent
- •Contraindications to MRI
- •Contraindication to gadolinium injection
结局指标
主要结局
comparison between histological results and oxygenation quantitative values from MRI and PET exams
时间窗: Inclusion, 1 month
Correlation study between anatomopatology data, product by prostatectomy anatomic piece, using HIF1-CAIX histological markers and: * on one hand PET FMISO uptake * on the other hand, MRI BOLD signal
次要结局
- quantitative analysis(Inclusion, 1 month)