FESPET Study: Female EStrogen recePtor in Endometrial Cancer Treatment (FESPET)

April 17, 2019 updated by: Radboud University Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Endometrial carcinoma is the most common gynecological malignancy in the western world, and with a current incidence of 18/100.000 women per year in the European Union, it affects around 65,000 new women each year. Due to the increased life expectancy and obesity, the incidence of endometrial cancer has increased in the last years, and is expected to rise in the coming years. Most patients present with early stage disease and have a favorable outcome. However, patients with metastatic disease have few treatment options with a poor prognosis.

Surgery is the primary treatment modality in endometrial cancer and defines the final surgicopathological stage according to the International Federation of Gynecology and Obstetrics (FIGO) staging system. Adjuvant treatment is based on final tumor grade and FIGO stage and consists of radiotherapy and-or chemotherapy. Hormonal therapy is considered as alternative treatment modality for: 1. patients who are not suitable for surgery, 2. patients who wish to maintain fertility, and 3. patients with metastatic disease. A recent review summarizes the available evidence on the effect of hormonal therapy in patients with advanced and recurrent endometrial cancer. The overall response rate based on a single biopsy taken prior to treatment, was 22%. In ER positive tumors, the response rate was 27% compared to 9% in ER negative tumors. In PR positive tumors 36% of patients responded, compared to 12% in PR negative tumors. Thus, the presence of ER and PR receptors on the tumor cell seems to be relevant for prediction of response to hormonal treatment. Yet, data concerning the percentage of ER and PR expression are lacking, and might underestimate the response to hormonal treatment in individual cases.

Analysis of the genomic landscape of endometrial cancer has shown marked genetic heterogeneity between biopsies of primary tumors and their corresponding metastases, suggesting that only a part of tumor cells in the primary tumor is involved in metastases. Also, loss of ER and PR expression is frequently observed in metastases from ER/PR positive primary tumors. These findings underline the relevance of obtaining a new biopsy to determine ER and PR expression in recurrent disease. This can be challenging since recurrences can be hard to reach by biopsies due to its location and multiplicity.

18F-FES PET CT (FES PET) is a novel imaging method based on positron emission tomography using a specific tracer targeting ER allowing the visualization of ER expression in tissue. FES PET allows non-invasive depiction and quantification of ER expression in all tumor lesions in a patient.

FES PET has been evaluated in breast cancer with a reported sensitivity of 69% to 100%, and a specificity of 80-100% for identifying ER positive tumor when compared to immunohistochemical expression of ER. In endometrial cancer, FES PET has been evaluated in only two studies. The first study included 19 patients with endometrial cancer with different FIGO stages that underwent FES PET prior to surgical resection. In this study a significant correlation between ER uptake on FES PET and ER immunohistochemical expression was observed. In the second study 22 patients were analyzed and classified into high risk (FIGO stage ≥Ic or grade ≥2) and low risk (FIGO stage ≤1b and grade 1) endometrioid type endometrial carcinoma. In the high risk group a significantly lower FES uptake was observed when compared to the low risk group, suggesting that FES PET could assist in identifying patients with high risk endometrial cancer. As shown by van Kruchten et al., FES PET could also be of value in the evaluation of response to hormonal therapy. In this study the results of serial FES PET scans are described in 16 patients with metastatic breast cancer treated with fulvestrant, a selective estrogen downregulator. Response to hormonal therapy was associated with reduced uptake on subsequent FES PET scans. So far, FES PET data are limited in endometrial cancer to one case report in which a decrease of estrogen uptake was observed upon medroxyprogesterone therapy in early stage endometrial cancer consistent with histological and clinical follow-up. Based on previous findings the aim of the current study is to explore the feasibility of FES PET scan in patients with endometrial cancer.

Study Type

Observational

Enrollment (Anticipated)

40

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

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patient with either

  • Primary endometrial cancer and planned hormonal treatment
  • Recurrent endometrial cancer and planned hormonal treatment

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
estrogen uptake on FES PET scan
Time Frame: Within 1 month of inclusion
Standard uptake volume of FES
Within 1 month of inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estrogen and Progesterone Receptor expression
Time Frame: Within 1 month of inclusion
Percentage of tumor cells expressing estrogen and progesterone receptor through immunohistochemical analysis of tissue biopsy material
Within 1 month of inclusion

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

Collaborators

University Medical Center Groningen
Haukeland University Hospital
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

  • Principal Investigator: JMA Pijnenborg, MD, PhD, Radboud university medical center

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, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

March 12, 2018

First Submitted That Met QC Criteria

April 4, 2018

First Posted (Actual)

April 5, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FESPET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers. This will be decided when a request for sharing of IPD is made

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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