Evaluation of the Interest of PET/CT at 18F-FDG in the Post-therapeutic Management of Cervical Cancer at an Advanced Stage. Multicenter Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- collection of the two décisions of RCP
研究概览
简要总结
A lot of studies have demonstrated the prognostic value of post therapy 18F-FDG PET/CT in the management of uterine cervical cancer. Post therapy 18F-FDG PET/CT is usually requested by a lot of clinicians.
Whereas 18F-FDG PET/CT is useful for prognosis in the follow-up, data are yet insufficient to clearly establish a formal recommendation.
This prospective multicenter observational study will evaluate the interest of post therapy 18F-FDG PET/CT in clinical management (within 2 months of treatment) in patients with cervical cancer at an advanced stage.
Main outcome :
The therapeutic impact of post therapy 18F-FDG PET/CT (within 2 months after the end of therapy) will be evaluated on the complete results included MRI.
Investigators will compare :
- decision of clinicians without 18F-FDG PET/CT results
- and decision of clinicians knowing entire results included results of 18F-FDG PET/CT.
详细描述
With approximately 3000 new cases estimated in France on 2017, the uterine cervical cancer is the twelfth cancer cause in women, responsible for 1000 deaths per year.
Management of uterine cervical cancer is well defined before treatment, especially for imaging including systematically pelvic MRI and 18F-FDG PET/CT.
A lot of studies have demonstrated the prognostic value of post therapy 18F-FDG PET/CT, due to semi quantitative parameters study, like the SUV max and delta SUV between pre and post therapy 18F-FDG PET/CT or qualitatively with the persistence of positive 18F-FDG PET/CT at the end of therapy.
Whereas 18F-FDG PET/CT is useful for prognosis in the follow-up, data are yet insufficient to clearly establish a formal recommendation.
Nevertheless, post therapy 18F-FDG PET/CT is still usually requested by a lot of clinicians.
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
- •Patient old ≥ 18 years
- •Uterine cervical cancer with locally-advanced (FIGO 2019 IB3 to IVA)
- •Histology: squamous cell carcinoma and adenocarcinoma
- •Feasibility of a curative treatment
- •Having formulated a non-opposition
排除标准
- •Minor patient < 18 years
- •Pregnancy or breastfeeding
- •Other type of tumor than squamous cell carcinoma and adenocarcinoma
- •FIGO 2019 < IB3 or > IVA
- •Non-eligibility for the examination
- •Contraindication to MRI and PET/CT
- •Previous history of cancer
- •Refusal of participation
结局指标
主要结局
collection of the two décisions of RCP
时间窗: Validated by six months follow up
To make statistical analysis possible, the collection of the two decisions will be chosen from three cases of care envisaged below: 1. Complete therapeutic response 2. Equivocal response: doubt about the presence of residual disease. 3. Strong suspicion of residual disease and/or progression Then, we will collect a percentage of patients with rightly changes on management induced by the result of the PET-CT at 18F-FDG.
The therapeutic impact of post therapy 18F-FDG PET/CT (within 2 months after the end of therapy) will be evaluated on the complete results included MRI.
时间窗: Validated by six months follow up
Investigators will compare * decision of clinicians without 18F-FDG PET/CT results * and decision of clinicians knowing entire results included results of 18F-FDG PET/CT. Gold Standard for the diagnosis of progression will be based on the conclusions of multi-disciplinary staff ruling on the results of composite data, including clinical examination, biology, histopathology, morphological imaging (MRI), functional imaging (PET/CT) and 6-month follow-up.
次要结局
- Prognostic factors(24 months follow up)
- Physiological analysis parameter(24 months follow up)
- Physiological analysis, hotspots study(24 months follow up)