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

Study Overview
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Brief Summary
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To assess the value of 18F-FDG PET/CT in the initial staging and detection of recurrent cases of endometrial cancer. To determine correlation between PET/CT derived parameters including SUVmax, TLG and MTV and clinic-pathological patient characteristics. To detect local and distant recurrence after therapy.

Detailed Description
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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.

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

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Device: 18F-FDG PET/CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| newly diagnosed endometrial cancer<br> | Device: 18F-FDG PET/CT<br>* The PET/CT procedure will be performed according to the institutional standard with 18F-FDG (0.8-1.2 mCi /kg) injection following 6 h fasting. Blood glucose was controlled to be <150 mg/dl. PET/CT from the vertex to the middle femur will be obtained 60 min after FDG injection. MDCT examination without IV contrast will be done for attenuation correction and anatomic localization followed by PET images from the skull vault to the mid-thigh region. Images of CT and corresponding functional PET images are displayed in axial, coronal and sagittal planes. PET/CT data will include tumor size and extension, LN invasion& distant metastasis SUVmax will be calculated for all positive lesions, Metabolic parameters including SUVmax, SUVmean, TLG & MTV will be calculated for primary tumor. Data of PET will be compared with other diagnostic imaging and postoperative pathologic data.<br>|
| Recurrent cases of endometrial cancer<br> | Device: 18F-FDG PET/CT<br>* The PET/CT procedure will be performed according to the institutional standard with 18F-FDG (0.8-1.2 mCi /kg) injection following 6 h fasting. Blood glucose was controlled to be <150 mg/dl. PET/CT from the vertex to the middle femur will be obtained 60 min after FDG injection. MDCT examination without IV contrast will be done for attenuation correction and anatomic localization followed by PET images from the skull vault to the mid-thigh region. Images of CT and corresponding functional PET images are displayed in axial, coronal and sagittal planes. PET/CT data will include tumor size and extension, LN invasion& distant metastasis SUVmax will be calculated for all positive lesions, Metabolic parameters including SUVmax, SUVmean, TLG & MTV will be calculated for primary tumor. Data of PET will be compared with other diagnostic imaging and postoperative pathologic data.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate diagnostic accuracy of PET/CT in the identification of EC stages |  | baseline |