Endometrial CancerPET/CTNCT05056259
Usefulness of 18F-FDG PET/CT in the Initial Staging and Surveillance of Endometrial Cancer Patients
An observational study of Endometrial Cancer, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- 18F-FDG PET/CT
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- Adult, Older adult
Study population: Any patient proved to have endometrial cancer by curettage or hysteroscopy.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
- 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.
Read the 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.
- Conditions
- Endometrial Cancer
- Being tested
- 18F-FDG PET/CT
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG PET/CTDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| newly diagnosed endometrial cancer | Not described Receives: Device: 18F-FDG PET/CT | |
| Recurrent cases of endometrial cancer | Not described Receives: Device: 18F-FDG PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (1)
To evaluate diagnostic accuracy of PET/CT in the identification of EC stages
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Jan 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Abdel-Baset Ahmed Ali Alsanory, Assiut University
- Investigators
- Hanan Gamaleldin Mostafa, M.D, Study chair, ProfessorEsraa Roshdey Hassan, M.D, Study director, Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056259
- Sponsor's protocol ID
- 18F-FDG PET/CT
- Acronym
- PET/CT
- Status last verified
- Oct 2021
- First submitted
- 15 Sep 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25220842Miller 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.
PubMed 31184787Alshahrani 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.
PubMed 30013598Gadducci 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.
PubMed 24769176Benedetti 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.
PubMed 24361787Crivellaro 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.
PubMed 32079712Gai 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.
PubMed 33829435De 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.
PubMed 30136163Rao 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.
PubMed 27196500Husby 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.
PubMed 26045311
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of 18F-FDG PET/CT in the Initial Staging and Surveillance of Endometrial Cancer Patients
- ClinicalTrials.gov ID
- NCT05056259
- Acronym / sponsor ID
- PET/CT / 18F-FDG PET/CT
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| newly diagnosed endometrial cancer | – | Device: 18F-FDG PET/CT |
| Recurrent cases of endometrial cancer | – | Device: 18F-FDG PET/CT |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Any patient proved to have endometrial cancer by curettage or hysteroscopy.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDG PET/CTThe 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. | Device | Recurrent cases of endometrial cancer, newly diagnosed endometrial cancer |
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.
Time frame: baseline
Analysis of metabolic parameters and correlation between it and histopathology
1 secondary outcome
To evaluate diagnostic accuracy of PET/CT in the identification of EC stages
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Background: PubMed 25220842Ferlay 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.
- Background: PubMed 31184787Miller 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.
- Background: PubMed 30013598Alshahrani 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.
- Background: PubMed 24769176Gadducci 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.
- Background: PubMed 24361787Benedetti 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.
- Background: PubMed 32079712Crivellaro 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.
- Background: PubMed 33829435Gai 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.
- Background: PubMed 30136163De 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.
- Background: PubMed 27196500Rao 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.
- Background: PubMed 26045311Husby 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanan Gamaleldin Mostafa, M.D study chair
Professor
Esraa Roshdey Hassan, M.D study director
Doctor
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya Abdelbaset Ahmed Alsanory, Master (01063490867, ayota17@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05056259, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.