Skip to main content
Clinical Trials/NCT03570866
NCT03570866
Unknown
Not Applicable

Positron Emission Tomography and Computed Tomography in the Management of Early Stage Intermediate and High-risk Endometrial Cancer

Università degli Studi dell'Insubria0 sites40 target enrollmentMay 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometrium Cancer
Sponsor
Università degli Studi dell'Insubria
Enrollment
40
Primary Endpoint
Diagnostic accuracy of positron emission tomography and computed tomography
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
May 1, 2024
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Università degli Studi dell'Insubria
Responsible Party
Principal Investigator
Principal Investigator

Antonio Simone Laganà

Principal Investigator

Università degli Studi dell'Insubria

Eligibility Criteria

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

Outcomes

Primary Outcomes

Diagnostic accuracy of positron emission tomography and computed tomography

Time Frame: 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 Outcomes

  • Progression free survival(Through study completion, an average of 5 year)
  • Overall survival(Through study completion, an average of 5 year)

Similar Trials