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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Epithelial Ovarian Cancer

Intervention / Treatment
-----------------
* Other: FES-PET


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FES-PET<br>Patients undergo FES-PET prior to obtaining histology | Other: FES-PET<br>* Patients undergo FES-PET prior to obtaining histology<br>|

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. | 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) | 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 | 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 |