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NCT Number: NCT01439490

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.

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Key information

Conditions

Epithelial Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University Medical Center Groningen

Groningen, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

FES-PET

Other

Patients undergo FES-PET prior to obtaining histology

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 23, 2011
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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