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

NCT03570866 | Unknown DMC

• 1 other identifier: ENCA-1
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometrium Cancer

Keywords

Endometrial cancer; Positron emission tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression free survival

  Through study completion, an average of 5 year

• Overall survival

  Through study completion, an average of 5 year

Study Arms (1)

Early stage endometrial cancer

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

Diagnostic Test: Positron emission tomography and computed tomography; Procedure: Surgical treatment

Interventions

Positron emission tomography and computed tomography DIAGNOSTIC_TEST

Preoperative staging of early stage intermediate and high-risk endometrial cancer with positron emission tomography and computed tomography.

Early stage endometrial cancer

Surgical treatment PROCEDURE

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.

Early stage endometrial cancer

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Woman referred for diagnosis of early stage intermediate and high-risk endometrial cancer that undergo PET/CT staging and standard surgical treatment.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead
• Universita di Verona: collaborator

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Positron Emission Tomography Computed Tomography; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Simone Garzon, M.D.

  Universita di Verona

  PRINCIPAL INVESTIGATOR

• Antonio Simone Laganà, M.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

• Massimo Franchi, M.D.

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Simone Laganà, M.D.

CONTACT

‭+39 329 6279579‬; antoniosimone.lagana@asst-settelaghi.it

Simone Garzon, M.D.

CONTACT

+393470782287; simone.garzon@univr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 27, 2018
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2024
• Last Updated: September 30, 2021

Record last verified: 2021-09