Usefulness of 18F-FDG PET/CT in the Initial Staging and Surveillance of Endometrial Cancer Patients

• Conditions: Endometrial Cancer
• Interventions: Device: 18F-FDG PET/CT

• Registration Number: NCT05056259
• Lead Sponsor: Assiut University

Brief Summary

1. To assess the value of 18F-FDG PET/CT in the initial staging and detection of recurrent cases of endometrial cancer.

2. To determine correlation between PET/CT derived parameters including SUVmax, TLG and MTV and clinic-pathological patient characteristics.

3. To detect local and distant recurrence after therapy.

Detailed Description

Endometrial cancer (EC) is one of the most common gynaecological malignancies worldwide.The incidence rate of uterine cancer in Egypt was 4.1 per 100,000.

The standard surgery consists of laparotomy, hysterectomy, and bilateral salpingo-oophorectomy. Maximal surgical cytoreduction is recommended for advanced EC. Prognostic impact of complete lymphadenectomy remains controversial, especially in early- stage disease.

With the aim of predicting extrauterine disease pre-operatively and optimizing surgical planning, several techniques have been evaluated, including 18F-fluoro-2-deoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT). PET /CT can be used to effectively and accurately diagnose EC pelvic lymph node metastasis and distant metastasis. It has great value in clinical staging, judging prognosis, diagnosing recurrence.

Radiomics analysis of the uterine primary tumor on pre-operative 18F-FDG PET images may help predict the presence of metastatic nodes, thus reducing false-negative results and increasing the sensitivity of the technique. The maximum standard uptake value (SUVmax), metabolic tumor volume (MTV) and total glycolysis (TLG) of primary lesions are significantly correlated with pathological tissue grading. Previous studies on metabolic parameters of primary lesions examined by 18F-FDG PET/CT for endometrial cancer mainly focused on SUVmax, However, SUVmax can only reflect the functional metabolic degree of the point. It cannot assess the overall metabolic situation of tumor. MTV and TLG can more comprehensively measure the glucose metabolic activity of tumor cells with more clinical value in reflecting the malignancy degree of tumor.

Study Timeline

• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-09-24
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-17
• Last Update Posted: 2021-10-25
• Study Start: 2022-01-01
• Primary Completion: 2023-09
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

• Patients proved to have endometrial cancer by curettage or hysteroscopy.
• Patients accepted surgery treatment, without anti-tumor and hormone therapy before surgery.
• Ability to stay still for the duration of the PET/CT scan (~15 minutes).
• Ability of the patient (or his/her guardian) to sign informed consent.

Exclusion Criteria

• Patients who recieved neoadjuvant therapy before PET/CT.
• Patients with tumors other than endometrial cancer.
• Pregnancy.
• Inability to give informed consent.
• Inability to stay still for the duration of the scan.
• Claustrophobia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
newly diagnosed endometrial cancer	18F-FDG PET/CT	-
Recurrent cases of endometrial cancer	18F-FDG PET/CT	-

Primary Outcome Measures

Name	Time	Method
To evaluate the correlation between metabolic parameters of primary lesions of endometrial cancer examined by 18F-FDG PET/CT and clinic-pathological features.	baseline	Analysis of metabolic parameters and correlation between it and histopathology

Secondary Outcome Measures

Name	Time	Method
To evaluate diagnostic accuracy of PET/CT in the identification of EC stages	baseline