Usefulness of 18F-FDG PET/CT in the Initial Staging and Surveillance of Endometrial Cancer Patients
NCT ID: NCT05056259
Last Updated: 2021-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
42 participants
OBSERVATIONAL
2022-01-01
2023-10-31
Brief Summary
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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
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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newly diagnosed endometrial cancer
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 with tumors other than endometrial cancer.
* Pregnancy.
* Inability to give informed consent.
* Inability to stay still for the duration of the scan.
* Claustrophobia
30 Years
FEMALE
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Aya Abdel-Baset Ahmed Ali Alsanory
Resident in nuclear medicine departement (South Egypt Cancer institute)
Principal Investigators
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Hanan Gamaleldin Mostafa, M.D
Role: STUDY_CHAIR
Professor
Esraa Roshdey Hassan, M.D
Role: STUDY_DIRECTOR
Doctor
Central Contacts
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References
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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.
Miller 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.
Alshahrani 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.
Gadducci 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.
Benedetti 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.
Crivellaro 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.
Gai 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.
De 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.
Rao 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.
Husby 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.
Other Identifiers
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18F-FDG PET/CT
Identifier Type: -
Identifier Source: org_study_id