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

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

Interventions

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.

Sponsors & Collaborators

• Universita di Verona

  collaborator OTHER

• Università degli Studi dell'Insubria

  lead OTHER

Principal Investigators

• Simone Garzon, M.D. · Universita di Verona

• Antonio Simone Laganà, M.D. · Università degli Studi dell'Insubria

• Massimo Franchi, M.D. · Universita di Verona

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-01

Primary Completion

2023-05-01

Completion

2024-05-01