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

October 17, 2021 updated by: Aya Abdel-Baset Ahmed Ali Alsanory, Assiut University
  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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Aya Abdelbaset Ahmed Alsanory, Master
  • Phone Number: 01063490867
  • Email: ayota17@gmail.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Any patient proved to have endometrial cancer by curettage or hysteroscopy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
newly diagnosed endometrial cancer
Device: 18F-FDG PET/CT

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.
Recurrent cases of endometrial cancer
Device: 18F-FDG PET/CT

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.

What is the study measuring?

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.
Time Frame: baseline
Analysis of metabolic parameters and correlation between it and histopathology
baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Hanan Gamaleldin Mostafa, M.D, Professor
  • Study Director: Esraa Roshdey Hassan, M.D, doctor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

September 23, 2021

First Posted (Actual)

September 24, 2021

Study Record Updates

Last Update Posted (Actual)

October 25, 2021

Last Update Submitted That Met QC Criteria

October 17, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18F-FDG PET/CT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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