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

Endometrium Cancer Clinical Trial

— ENCA-1  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03570866
• Other study ID #: ENCA-1
• Status: Not yet recruiting
• Start date: May 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: September 2021
• Source: Università degli Studi dell'Insubria
• Contact: Antonio Simone Laganà, M.D.
• Phone: ?+39 329 6279579?
• Email: antoniosimone.lagana[@]asst-settelaghi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Endometrium Cancer

Intervention

Diagnostic Test:
• Positron emission tomography and computed tomography
Preoperative staging of early stage intermediate and high-risk endometrial cancer with positron emission tomography and computed tomography.

Procedure:
• Surgical treatment
Surgical treatment of early stage intermediate and high-risk endometrial cancer by usual practice: peritoneal cytology, total abdominal hysterectomy, bilateral salpingo-oophorectomy, systematic pelvic and para-aortic lymphadenectomy.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria	Universita di Verona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of positron emission tomography and computed tomography	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.	Through study completion, an average of 5 year
Secondary	Progression free survival	Events of disease recurrence in the study group	Through study completion, an average of 5 year
Secondary	Overall survival	Events of death in the study group	Through study completion, an average of 5 year