Epithelial Ovarian Cancer
Conditions
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.
Interventions
OTHERFES-PET
Patients undergo FES-PET prior to obtaining histology
Sponsors
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The feasibility of FES-PET to visualize and quantify ER-positive lesions in epithelial ovarian cancer. | 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
| Measure | Time frame | Description |
|---|---|---|
| Correlation between FES-PET and immunohistochemistry (IHC) | 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. |
| Concordance between CT-scan and FES-PET | 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. |
Countries
Netherlands
Outcome results
None listed