FES-PET to Determine ER-expression in Epithelial Ovarian Cancer

May 3, 2024 updated by: University Medical Center Groningen

Feasibility Study: FES-PET to Determine ER-expression in Epithelial Ovarian Cancer

Estrogens are implicated in the development of ovarian cancer and estrogen receptors (ER) alpha and beta are present in 20-100% of ovarian cancer patients. For this reason, antihormonal therapy with anti-estrogens or ER-antagonists is potentially an attractive treatment option. However, only a small proportion of patients (5-19%) will respond to antihormonal therapy. ER-expression in ER-positive breast cancer can be assessed by positron emission tomography (PET) with [18F]fluoroestradiol (FES). In this study the investigators will evaluate whether FES-PET can be used to visualize and quantify ER-expression in ovarian cancer. If these results are positive, this would warrant further exploration of FES-PET imaging in ovarian cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigators will evaluate whether FES-PET can be used to visualize and quantify ER-expression in ovarian cancer. If these results are positive, this would warrant further exploration of FES-PET imaging in ovarian cancer.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands
        • University Medical Center Groningen

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histological evidence or high clinical suspicion of epithelial ovarian cancer
  2. The presence of at least one measurable lesion (RECIST version 1.1).
  3. Histology or cytology can be obtained (may be ascites)
  4. Eastern Cooperative Oncology Group performance status 0-2.
  5. Postmenopausal status (defined as either >45 years with amenorrhea >12 months, or prior bilateral ovariectomy)
  6. No history of other ER-positive malignancies
  7. Signed written informed consent
  8. Able to comply with the protocol

Exclusion Criteria:

  1. Use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, during the 5 weeks before entry into the study
  2. Life-expectancy ≤ 3 months

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FES-PET
Patients undergo FES-PET prior to obtaining histology
Other: FES-PET
Patients undergo FES-PET prior to obtaining histology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The feasibility of FES-PET to visualize and quantify ER-positive lesions in epithelial ovarian cancer.
Time Frame: approximately 1 month
Ovarian cancer patients planned for surgery or in which histology/cytology will be obtained, will undergo FES-PET/CT. FES-PET/CT will be qualitatively analyzed to determine whether ovarian cancer lesions can be visualized. FES-uptake will be quantified for all known lesions. Patient material will be stained for ER-expression to determine whether ER-positive metastases show FES-uptake.
approximately 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between FES-PET and immunohistochemistry (IHC)
Time Frame: approximately 1 month
FES-uptake will be calculated for each lesions. Quantitative FES-uptake will be correlated to semi-quantitative IHC-scoring for ER-alpha, ER-bèta, and progesterone receptor.
approximately 1 month
Concordance between CT-scan and FES-PET
Time Frame: approximately 1 month
CT-scan will be analyzed by a radiologist and lesions will classified into benign, equivocal and malignant lesions. FES-PET will be analyzed by a nuclear medicine physician and lesions will be classified. Concordance between FES-PET and CT-scan will be described. For discordant lesions, histology will be used as golden standard whenever available.
approximately 1 month

Collaborators and Investigators

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

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Geke AP Hospers, MD, PhD, University Medical Center Groningen

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

August 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

September 20, 2011

First Submitted That Met QC Criteria

September 22, 2011

First Posted (Estimated)

September 23, 2011

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RUG2011-0704

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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