Stratifying Endometrial Cancer Patients Using a PET/MRI Prognostic Model
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- MRI imaging evaluation
研究概览
简要总结
Endometrial cancer (EC) is the most common gynecological malignancy in high-income countries. Prognosis and treatment are dictated by cancer histological subtype and grade coupled with surgical staging as described by Surgical International Federation of Gynecology and Obstetrics (FIGO) staging system. Surgery is the elective standard treatment and used for staging of EC. The purpose of this study is to collect images from a simultaneous PET/MRI study from which to extrapolate a preoperative, non-invasive, prognostic model.
详细描述
Magnetic resonance imaging (MRI) is the most frequently used imaging tool in preoperative staging of endometrial cancer. FDG-PET has demonstrated higher sensitivity than MRI in detecting nodal involvement and metastatic disease and is currently used in adjunction to MRI. Distinct MRI and FDG-PET parameters correlate well with tumor aggressiveness and can and have been used as prognostic factors. The Investigators believe that the combination of data from these two imaging techniques, from which different derived tumor features can be extrapolated, can stratify patients in high-risk and low-risk groups already preoperatively. The aim of combined techniques is to collect large amounts of data leveraging advantages of both modalities (MR's strengths in local staging and PET's strengths in nodal staging) in a single scan from which to extrapolate a preoperative, non-invasive, prognostic model.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •histopathological confirmation of a primary endometrial cancer
- •age > 18 years
- •no contraindication to surgery (comorbidity, contraindication or lack of consent)
- •no contraindication to preoperative imaging
- •visible tumor at imaging
- •signed inform consent.
排除标准
- •patients unsuitable for surgical intervention (comorbidity, contraindication or lack of consent, poor performance status)
- •age < 18 years, c) inability to complete the needed imaging examination (ie, severe claustrophobia)
- •any additional medical condition that may significantly interfere with study compliance
- •all the contraindication for MRI (ie, pacemaker).
结局指标
主要结局
MRI imaging evaluation
时间窗: 0-2 years
Depth of myometrial invasion
MRI evaluation
时间窗: 0-2 years
Measure tumor volume and correlate to surgical specimen
MRI imaging
时间窗: 0-2 years
Changes in ADC normale versus tumor myometrium
MRI
时间窗: 0-2 years
positive lymph node evaluation
PET imaging evaluation
时间窗: 0-2 years
PET positive lymph nodes
DCE-MRI perfusion parameters
时间窗: 0-2 years
Define tumor perfusion in normal versus tumor myometrium
PET imaging
时间窗: 0-2 years
Tumor/positive lymph node/metastases SUV values
次要结局
- Correlate PET and MRI derived functional and morphological parameters with histology(0-5 years)
- Measure tumor angiogenesis(0-2 years)
研究者
Francesco De Cobelli
Head, Radiology Department
IRCCS San Raffaele