Usefulness of 18F-FDG PET/CT in the Initial Staging and Surveillance of Endometrial Cancer Patients
PET/CT
1 other identifier
observational
42
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2021
CompletedFirst Posted
Study publicly available on registry
September 24, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedOctober 25, 2021
October 1, 2021
1.7 years
September 15, 2021
October 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To evaluate diagnostic accuracy of PET/CT in the identification of EC stages
baseline
Study Arms (2)
newly diagnosed endometrial cancer
Recurrent cases of endometrial cancer
Interventions
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.
Eligibility Criteria
Any patient proved to have endometrial cancer by curettage or hysteroscopy.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (10)
Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
PMID: 25220842BACKGROUNDMiller KD, Nogueira L, Mariotto AB, Rowland JH, Yabroff KR, Alfano CM, Jemal A, Kramer JL, Siegel RL. Cancer treatment and survivorship statistics, 2019. CA Cancer J Clin. 2019 Sep;69(5):363-385. doi: 10.3322/caac.21565. Epub 2019 Jun 11.
PMID: 31184787BACKGROUNDAlshahrani S, Soliman AS, Hablas A, Ramadan M, Meza JL, Remmenga S, Seifeldein IA, Chamberlain RM. Changes in Uterine Cancer Incidence Rates in Egypt. Obstet Gynecol Int. 2018 Jun 14;2018:3632067. doi: 10.1155/2018/3632067. eCollection 2018.
PMID: 30013598BACKGROUNDGadducci A, Cosio S, Landoni F, Maggino T, Zola P, Sostegni B, Bellicini A, Fuso L, Cristofani R, Sartori E. Adjuvant treatment and analysis of failures in patients with high-risk FIGO Stage Ib-II endometrial cancer: an Italian multicenter retrospective study (CTF study). Gynecol Oncol. 2014 Jul;134(1):29-35. doi: 10.1016/j.ygyno.2014.04.008. Epub 2014 Apr 24.
PMID: 24769176BACKGROUNDBenedetti Panici P, Basile S, Salerno MG, Di Donato V, Marchetti C, Perniola G, Palagiano A, Perutelli A, Maneschi F, Lissoni AA, Signorelli M, Scambia G, Tateo S, Mangili G, Katsaros D, Campagnutta E, Donadello N, Greggi S, Melpignano M, Raspagliesi F, Cormio G, Grassi R, Franchi M, Giannarelli D, Fossati R, Torri V, Croce C, Mangioni C. Secondary analyses from a randomized clinical trial: age as the key prognostic factor in endometrial carcinoma. Am J Obstet Gynecol. 2014 Apr;210(4):363.e1-363.e10. doi: 10.1016/j.ajog.2013.12.025. Epub 2013 Dec 19.
PMID: 24361787BACKGROUNDCrivellaro C, Landoni C, Elisei F, Buda A, Bonacina M, Grassi T, Monaco L, Giuliani D, Gotuzzo I, Magni S, Di Martino G, Delle Marchette M, Guerra L, Landoni F, Fruscio R, Messa C, De Bernardi E. Combining positron emission tomography/computed tomography, radiomics, and sentinel lymph node mapping for nodal staging of endometrial cancer patients. Int J Gynecol Cancer. 2020 Mar;30(3):378-382. doi: 10.1136/ijgc-2019-000945. Epub 2020 Feb 19.
PMID: 32079712BACKGROUNDGai QZ, Lv YB, Li GY, Zhang DQ, Gao Z, Fang XH. Value of metabolic parameters of primary lesions examined by 18F-FDG PET/CT for endometrial cancer in preoperative evaluation. Eur Rev Med Pharmacol Sci. 2021 Mar;25(6):2493-2502. doi: 10.26355/eurrev_202103_25412.
PMID: 33829435BACKGROUNDDe Bernardi E, Buda A, Guerra L, Vicini D, Elisei F, Landoni C, Fruscio R, Messa C, Crivellaro C. Radiomics of the primary tumour as a tool to improve 18F-FDG-PET sensitivity in detecting nodal metastases in endometrial cancer. EJNMMI Res. 2018 Aug 22;8(1):86. doi: 10.1186/s13550-018-0441-1.
PMID: 30136163BACKGROUNDRao L, Wang X, Zong Z, Chen Z, Shi X, Yi C, Zhang X, Yang Z. PET-CT for Evaluation of Spleen and Liver 18F-FDG Diffuse Uptake Without Lymph Node Enlargement in Lymphoma. Medicine (Baltimore). 2016 May;95(20):e3750. doi: 10.1097/MD.0000000000003750.
PMID: 27196500BACKGROUNDHusby JA, Reitan BC, Biermann M, Trovik J, Bjorge L, Magnussen IJ, Salvesen OO, Salvesen HB, Haldorsen IS. Metabolic Tumor Volume on 18F-FDG PET/CT Improves Preoperative Identification of High-Risk Endometrial Carcinoma Patients. J Nucl Med. 2015 Aug;56(8):1191-8. doi: 10.2967/jnumed.115.159913. Epub 2015 Jun 4.
PMID: 26045311BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hanan Gamaleldin Mostafa, M.D
Professor
- STUDY DIRECTOR
Esraa Roshdey Hassan, M.D
Doctor
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident in nuclear medicine departement (South Egypt Cancer institute)
Study Record Dates
First Submitted
September 15, 2021
First Posted
September 24, 2021
Study Start
January 1, 2022
Primary Completion
September 1, 2023
Study Completion
October 1, 2023
Last Updated
October 25, 2021
Record last verified: 2021-10