Brief Title
PET/CT in the Management of Patients With Early Stage Endometrial Cancer
Official Title
Positron Emission Tomography and Computed Tomography in the Management of Early Stage Intermediate and High-risk Endometrial Cancer
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.
Study Type
Observational
Primary Outcome
Diagnostic accuracy of positron emission tomography and computed tomography
Secondary Outcome
Progression free survival
Condition
Endometrium Cancer
Intervention
Positron emission tomography and computed tomography
Study Arms / Comparison Groups
Early stage endometrial cancer
Description: Women with diagnosis of intermediate and high-risk early stage endometrial cancer.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
40
Start Date
May 1, 2019
Completion Date
May 1, 2022
Primary Completion Date
May 1, 2021
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
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Simone Garzon, M.D., +39 329 6279579, [email protected]
Administrative Informations
NCT ID
NCT03570866
Organization ID
ENCA-1
Responsible Party
Principal Investigator
Study Sponsor
Università degli Studi dell'Insubria
Collaborators
Universita di Verona
Study Sponsor
Simone Garzon, M.D., Principal Investigator, Universita di Verona
Verification Date
June 2018