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.
Epithelial Ovarian Cancer
Other: Diagnostic intervention: Positron Emission Tomography with 16-alpha-[18-fluoro]-17betaestradiol
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
|Official Title:||Feasibility Study: FES-PET to Determine ER-expression in Epithelial Ovarian Cancer|
- The feasibility of FES-PET to visualize and quantify ER-positive lesions in epithelial ovarian cancer. [ Time Frame: approximately 1 month ] [ Designated as safety issue: No ]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.
- Correlation between FES-PET and immunohistochemistry (IHC) [ Time Frame: approximately 1 month ] [ Designated as safety issue: No ]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.
- Concordance between CT-scan and FES-PET [ Time Frame: approximately 1 month ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Epithelial ovarian cancer
Postmenopausal patients with histological evidence of epithelial ovarian cancer, or high clinical clinical suspicion (with proven malignant ascites) and high probability of epithelial ovarian cancer will undergo FES-PET examination. Both patients with primary ovarian cancer as well as patients with advanced or recurrent disease are eligible.
|Other: Diagnostic intervention: Positron Emission Tomography with 16-alpha-[18-fluoro]-17betaestradiol|
|Contact: Geke AP Hospers, MD, PhD||+31 50 firstname.lastname@example.org|
|University Medical Center Groningen||Recruiting|
|Contact: Geke AP Hospers, MD, PhD +31 50 3616161 email@example.com|
|Contact: E GE de Vries, MD, PhD +31 50 3616161 firstname.lastname@example.org|
|Principal Investigator: Geke AP Hospers, MD, PhD|
|Principal Investigator:||Geke AP Hospers, MD, PhD||University Medical Centre Groningen|