FESPET Study: Female EStrogen recePtor in Endometrial Cancer Treatment

NCT03489473 | Unknown DMC

• 1 other identifier: FESPET
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Endometrial cancer is the most common gynecological malignancy in the western world and its incidence is expected to increase in the coming years due to obesity. Major treatment modalities include surgery, radiotherapy and chemotherapy. Hormonal therapy can be considered in primary treatment if other treatment modalities are not feasible and in treatment for recurrent disease. Hormonal treatment has shown to be more effective in endometrial cancers expressing estrogen (ER) and progesterone receptor (PR). Tumor heterogeneity frequently causes loss of expression of ER and PR in metastasis compared to primary tumors. The FES PET CT scan combines PET-CT scan with an estrogen tracer, thus allowing non invasive visualisation of estrogen receptor, even in patients with metastasis that are difficult to reach for biopsy. FES PET has been shown to relate well to ER expression and to treatment response in breast cancer. This study explores the feasibility of the FES PET scan in endometrial cancer patients.

Conditions

Endometrial Cancer

Keywords

Hormonal therapy; FES PET scan; Estrogen receptor

Outcome Measures

Primary Outcomes (1)

• estrogen uptake on FES PET scan

  Standard uptake volume of FES

  Within 1 month of inclusion

Secondary Outcomes (1)

• Estrogen and Progesterone Receptor expression

  Within 1 month of inclusion

Interventions

18F-FES PET CT scan DIAGNOSTIC_TEST

PET CT scan with estrogen tracer

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Gender identity since the study population is found in patients with endometrial cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with either * Primary endometrial cancer and planned hormonal treatment * Recurrent endometrial cancer and planned hormonal treatment

You may qualify if:

• Primary or metastatic endometrial cancer in which hormonal treatment is the planned treatment
• Postmenopausal status
• All histologic types of endometrial cancer (e.g. endometrioid, clear cell, serous subtype)
• Availability of recent (micro)curettage or biopsy

You may not qualify if:

• Intercurrent treatment between biopsy taking and start of hormonal treatment
• Sarcoma of the uterus
• Contra-indications to perform a PET-CT scan or a CT scan with intravenous contrast
• Use of hormonal therapy in the three months preceding performance of FES PET

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• University Medical Center Groningen: collaborator
• Haukeland University Hospital: collaborator

Related Publications (14)

• Basen-Engquist K, Chang M. Obesity and cancer risk: recent review and evidence. Curr Oncol Rep. 2011 Feb;13(1):71-6. doi: 10.1007/s11912-010-0139-7.

  PMID: 21080117 BACKGROUND

• Carlson MJ, Thiel KW, Leslie KK. Past, present, and future of hormonal therapy in recurrent endometrial cancer. Int J Womens Health. 2014 May 2;6:429-35. doi: 10.2147/IJWH.S40942. eCollection 2014.

  PMID: 24833920 BACKGROUND

• Amant F, Mirza MR, Koskas M, Creutzberg CL. Cancer of the corpus uteri. Int J Gynaecol Obstet. 2015 Oct;131 Suppl 2:S96-104. doi: 10.1016/j.ijgo.2015.06.005. No abstract available.

  PMID: 26433681 BACKGROUND

• Ethier JL, Desautels DN, Amir E, MacKay H. Is hormonal therapy effective in advanced endometrial cancer? A systematic review and meta-analysis. Gynecol Oncol. 2017 Oct;147(1):158-166. doi: 10.1016/j.ygyno.2017.07.002. Epub 2017 Jul 6.

  PMID: 28689667 BACKGROUND

• Gibson WJ, Hoivik EA, Halle MK, Taylor-Weiner A, Cherniack AD, Berg A, Holst F, Zack TI, Werner HM, Staby KM, Rosenberg M, Stefansson IM, Kusonmano K, Chevalier A, Mauland KK, Trovik J, Krakstad C, Giannakis M, Hodis E, Woie K, Bjorge L, Vintermyr OK, Wala JA, Lawrence MS, Getz G, Carter SL, Beroukhim R, Salvesen HB. The genomic landscape and evolution of endometrial carcinoma progression and abdominopelvic metastasis. Nat Genet. 2016 Aug;48(8):848-55. doi: 10.1038/ng.3602. Epub 2016 Jun 27.

  PMID: 27348297 BACKGROUND

• Geels YP, van der Putten LJM, van Tilborg AAG, Nienhaus BEC, van den Berg-van Erp SH, Snijders MPLM, van der Wurff A, Massuger LFAG, Bulten J, Pijnenborg JMA. Immunohistochemical Profiles of Endometrioid Endometrial Carcinomas With and Without Metastatic Disease. Appl Immunohistochem Mol Morphol. 2018 Mar;26(3):173-179. doi: 10.1097/PAI.0000000000000402.

  PMID: 27299188 BACKGROUND

• Vandenput I, Trovik J, Leunen K, Wik E, Stefansson I, Akslen L, Moerman P, Vergote I, Salvesen H, Amant F. Evolution in endometrial cancer: evidence from an immunohistochemical study. Int J Gynecol Cancer. 2011 Feb;21(2):316-22. doi: 10.1097/IGC.0b013e31820575f5.

  PMID: 21734474 BACKGROUND

• Tsujikawa T, Yoshida Y, Kiyono Y, Kurokawa T, Kudo T, Fujibayashi Y, Kotsuji F, Okazawa H. Functional oestrogen receptor alpha imaging in endometrial carcinoma using 16alpha-[(1)(8)F]fluoro-17beta-oestradiol PET. Eur J Nucl Med Mol Imaging. 2011 Jan;38(1):37-45. doi: 10.1007/s00259-010-1589-8. Epub 2010 Aug 18.

  PMID: 20717823 BACKGROUND

• Tsujikawa T, Yoshida Y, Kudo T, Kiyono Y, Kurokawa T, Kobayashi M, Tsuchida T, Fujibayashi Y, Kotsuji F, Okazawa H. Functional images reflect aggressiveness of endometrial carcinoma: estrogen receptor expression combined with 18F-FDG PET. J Nucl Med. 2009 Oct;50(10):1598-604. doi: 10.2967/jnumed.108.060145. Epub 2009 Sep 16.

  PMID: 19759112 BACKGROUND

• van Kruchten M, de Vries EG, Glaudemans AW, van Lanschot MC, van Faassen M, Kema IP, Brown M, Schroder CP, de Vries EF, Hospers GA. Measuring residual estrogen receptor availability during fulvestrant therapy in patients with metastatic breast cancer. Cancer Discov. 2015 Jan;5(1):72-81. doi: 10.1158/2159-8290.CD-14-0697. Epub 2014 Nov 7.

  PMID: 25380844 BACKGROUND

• Yoshida Y, Kurokawa T, Sawamura Y, Shinagawa A, Okazawa H, Fujibayashi Y, Kotsuji F. The positron emission tomography with F18 17beta-estradiol has the potential to benefit diagnosis and treatment of endometrial cancer. Gynecol Oncol. 2007 Mar;104(3):764-6. doi: 10.1016/j.ygyno.2006.10.024. Epub 2006 Dec 6.

  PMID: 17156828 BACKGROUND

• Trovik J, Wik E, Werner HM, Krakstad C, Helland H, Vandenput I, Njolstad TS, Stefansson IM, Marcickiewicz J, Tingulstad S, Staff AC; MoMaTEC study group; Amant F, Akslen LA, Salvesen HB. Hormone receptor loss in endometrial carcinoma curettage predicts lymph node metastasis and poor outcome in prospective multicentre trial. Eur J Cancer. 2013 Nov;49(16):3431-41. doi: 10.1016/j.ejca.2013.06.016. Epub 2013 Aug 8.

  PMID: 23932335 BACKGROUND

• Tangen IL, Werner HM, Berg A, Halle MK, Kusonmano K, Trovik J, Hoivik EA, Mills GB, Krakstad C, Salvesen HB. Loss of progesterone receptor links to high proliferation and increases from primary to metastatic endometrial cancer lesions. Eur J Cancer. 2014 Nov;50(17):3003-10. doi: 10.1016/j.ejca.2014.09.003. Epub 2014 Sep 30.

  PMID: 25281525 BACKGROUND

• Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

  PMID: 19097774 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• JMA Pijnenborg, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Willem Jan van Weelden, MD

CONTACT

0031643274577; willemjan.vanweelden@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: April 5, 2018
• Study Start: January 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 18, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share