Clinical trial · Observational
PET/CT in the Management of Patients With Early Stage Endometrial Cancer
Positron Emission Tomography and Computed Tomography in the Management of Early Stage Intermediate and High-risk Endometrial Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrium Cancer | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Positron emission tomography and computed tomography | Diagnostic Test | — | UNRESOLVED |
| Surgical treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Early stage endometrial cancer
- description
- Women with diagnosis of intermediate and high-risk early stage endometrial cancer.
- interventionNames
- Diagnostic Test: Positron emission tomography and computed tomography
- Procedure: Surgical treatment
Primary outcomes (1)
- measure
- Diagnostic accuracy of positron emission tomography and computed tomography
- timeFrame
- Through study completion, an average of 5 year
- description
- 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 (2)
- measure
- Progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available