Positron Emission Tomography and Computed Tomography in the Management of Early Stage Intermediate and High-risk Endometrial Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Diagnostic accuracy of positron emission tomography and computed tomography
研究概览
简要总结
Endometrial cancer (EC) is the most common gynecologic malignancy in the developed countries and is the fifth most common cancer among women worldwide. Typically present well or moderately differentiated, early stage endometrioid histotype with a prognosis usually favorable. Pelvic lymph nodes (LNs) represent the most common site of extra-uterine disease in patients with clinical early stage disease and the role of lymphadenectomy in early stage EC has been one of the major controversies in gynecology oncology. Lymphadenectomy doesn't improve survival or reduce disease recurrence although supported to provide prognostic information and allowing tailoring of adjuvant therapy. Nevertheless, lymphadenectomy is not performed without serious short-term and long-term morbidity. Although surgical staging is the most accurate and standard method to determine LNs involvement, the introduction in clinical practice of a non-invasive modality that allows an accurate staging of EC would be essential. Available evidence report the accuracy of Positron Emission Tomography and Computed Tomography (PET/CT) for the detection of LN metastasis in EC with a sensitivity of 63% and specificity of 94.7%. This prospective comparative analysis between PET/CT, histological findings, and follow up data will be performed to investigate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of integrated PET/CT for nodal staging of EC per patient and per LN chain analyses, in women affected by intermediate (grade 1 and 2 endometrioid lesions with deep myometrial invasion > 50% or grade 3 endometrioid lesion with < 50% myometrial invasion) or high risk (grade 3 endometrioid lesion with deep myometrial invasion > 50% or non-endometrioid histotype) early-stage EC. Furthermore, the preoperative classification of EC in intermediate and high-risk class will allow to investigate its prognostic value.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with diagnosis of early stage intermediate and high-risk endometrial cancer.
排除标准
- •Not eligible for standard surgical treatment; Not eligible for preoperative staging with PET/CT
结局指标
主要结局
Diagnostic accuracy of positron emission tomography and computed tomography
时间窗: Through study completion, an average of 5 year
Comparing Positron emission tomography and computed tomography results with Histopathological findings served as the standard of reference. True positive, True negative, False positive, False negative. Sensitivity, Specificity, Negative predictive value, Positive predictive value.
次要结局
- Progression free survival(Through study completion, an average of 5 year)
- Overall survival(Through study completion, an average of 5 year)
研究者
Antonio Simone Laganà
Principal Investigator
Università degli Studi dell'Insubria
