Brief Title
Usefulness of 18F-FDG PET/CT in the Initial Staging and Surveillance of Endometrial Cancer Patients
Official Title
Usefulness of 18F-FDG PET/CT in the Initial Staging and Surveillance of Endometrial Cancer Patients
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 Type
Observational
Primary Outcome
To evaluate the correlation between metabolic parameters of primary lesions of endometrial cancer examined by 18F-FDG PET/CT and clinic-pathological features.
Secondary Outcome
To evaluate diagnostic accuracy of PET/CT in the identification of EC stages
Condition
Endometrial Cancer
Intervention
18F-FDG PET/CT
Study Arms / Comparison Groups
newly diagnosed endometrial cancer
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
42
Start Date
January 1, 2022
Completion Date
October 2023
Primary Completion Date
September 2023
Eligibility Criteria
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
Gender
Female
Ages
30 Years - N/A
Contacts
Hanan Gamaleldin Mostafa, M.D, 01063490867, [email protected]
Administrative Informations
NCT ID
NCT05056259
Organization ID
18F-FDG PET/CT
Responsible Party
Principal Investigator
Study Sponsor
Assiut University
Study Sponsor
Hanan Gamaleldin Mostafa, M.D, Study Chair, Professor
Verification Date
October 2021