PET/CT in the Management of Patients With Early Stage Endometrial Cancer

• Conditions: Endometrium Cancer
• Interventions: Diagnostic Test: Positron emission tomography and computed tomography; Procedure: Surgical treatment

• Registration Number: NCT03570866
• Lead Sponsor: Università degli Studi dell'Insubria

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-31
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-06-27
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-30
• Study Start: 2022-05-01
• Primary Completion: 2023-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Women with diagnosis of early stage intermediate and high-risk endometrial cancer.

Exclusion Criteria

• Not eligible for standard surgical treatment; Not eligible for preoperative staging with PET/CT

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early stage endometrial cancer	Positron emission tomography and computed tomography	Women with diagnosis of intermediate and high-risk early stage endometrial cancer.
Early stage endometrial cancer	Surgical treatment	Women with diagnosis of intermediate and high-risk early stage endometrial cancer.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of positron emission tomography and computed tomography	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.

Secondary Outcome Measures

Name	Time	Method
Progression free survival	Through study completion, an average of 5 year	Events of disease recurrence in the study group
Overall survival	Through study completion, an average of 5 year	Events of death in the study group