Prognostic and Diagnostic Added Value of Medical Imaging in Staging and Treatment Planning of Gynecological Cancer (PRODIGYN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) and overall survival (OS)
研究概览
简要总结
The goal of this observational study is to learn about the added diagnostic and prognostic value of advanced medical imaging procedures in cervical cancer, endometrial cancer and ovarian cancer. The main questions it aims to answer are:
- Does advanced medical imaging predict survival?
- Can advanced medical imaging improve radiotherapy target planning?
- Are advanced medical imaging results associated with risk markers found in tumor tissue?
Participants will
- Undergo four additional imaging procedures, as compared to clinical routine examinations, two at baseline and two after three months.
- Be subject to clinical follow-up for five years.
详细描述
This study has a retrospective and a prospective part, where the main aims are to:
- Retrospectively validate the added value of radiological staging to clinical staging according to the International Federation of Gynecology and Obstetrics (FIGO) tumor classification system, in cervical cancer, endometrial cancer, and epithelial ovarian cancer.
- Prospectively identify prognostic biomarkers with 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG)-positron emission tomography (PET)/CT and FDG-PET/MRI in cervical cancer, endometrial cancer, and epithelial ovarian cancer
- Assess the possible effect of PET/MRI on radiotherapy target delineation in cervical cancer
- Improve non-invasive lymph node staging in endometrial cancer
- Develop a machine learning decision support tool for characterization of ovarian lesions
Material and methods (retrospective):
All eligible patients from the multi-disciplinary gynecological tumor conference at Umea University Hospital during 2013-2022, with newly diagnosed cervical, endometrial, or epithelial ovarian cancer, known cFIGO, >18 years old, and no other known current or previous malignancy within the last 10 years, will be included in a retrospective evaluation of radiological stage (rFIGO) based on all pre-operative imaging (MRI, CT and FDG-PET/CT), clinical stage (cFIGO) based on examination under anesthesia (EUA), and histopathological stage (pFIGO) based on available surgical and histopathological findings. The analysis will be carried out in two cohort groups - 2016-01-01-2018-05-31, and 2018-06-01-2022-06-01, before and after the implementation of the 2018 revised FIGO classification, after which the cFIGO may be influenced to larger extent by imaging results. For all epithelial ovarian cancer patients, Ovarian-Reporting and Data System (O-RADS) score will be annotated for each MRI examination.
Agreement between rFIGO and cFIGO will be evaluated, and if feasible, compared to pFIGO. The investigators will thus be able to validate rFIGO in cervical cancer with cFIGO up to Ib2, and in endometrial and epithelial ovarian cancer treated with surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Previously untreated primary cervical, endometrial, or strongly suspected epithelial ovarian cancer.
- •Known clinical FIGO stage.
- •>18 years old.
- •No other known current or previous malignancy within the last 10 years.
排除标准
- •Imaging findings suggestive of other primary malignancy.
- •Previously included suspected epithelial ovarian cancer, later confirmed to be other diagnosis than epithelial ovarian cancer or "cancer abdominis".
- •MRI incompatible devices or patient unable to undergo MRI.
结局指标
主要结局
Progression-free survival (PFS) and overall survival (OS)
时间窗: 5 years
PFS and OS at 5 years
次要结局
- Incidence of radiation therapy side effects(5 years)
- Degree of agreement between FDG-PET/MRI and sentinel node histopathology(0 months)
- Odds ratio between FDG-PET maximum standardized uptake value (SUVmax) and histopathological N0 and N1 groups(0 months)
- Odds ratio between FDG-PET mean standardized uptake value (SUVmean) and histopathological N0 and N1 groups(0 months)
- Odds ratio between FDG-PET functional tumor volume (FTV) and histopathological N0 and N1 groups(0 months)
- Odds ratio between FDG-PET total lesion glycolysis (TLG) and histopathological N0 and N1 groups(0 months)
- Correlation between immunohistochemical and molecular analyses P53, Ki-67, ER, D240 and CD31, MSI, BRCA-, and POLE-mutations, and FDG-PET maximum standardized uptake value (SUVmax)(0 months)
- Correlation between immunohistochemical and molecular analyses P53, Ki-67, ER, D240 and CD31, MSI, BRCA-, and POLE-mutations, and FDG-PET mean standardized uptake value (SUVmean)(0 months)
- Correlation between immunohistochemical and molecular analyses P53, Ki-67, ER, D240 and CD31, MSI, BRCA-, and POLE-mutations, and FDG-PET functional tumor volume (FTV)(0 months)
- Degree of agreement between machine learning and radiologists´s reporting of O-RADS(0 months)
- Correlation between immunohistochemical and molecular analyses P53, Ki-67, ER, D240 and CD31, MSI, BRCA-, and POLE-mutations, and FDG-PET total lesion glycolysis (TLG)(0 months)