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

Phase 2

Completed

• Conditions: Epithelial Ovarian Cancer
• Interventions: Other: FES-PET

• Registration Number: NCT01439490
• Lead Sponsor: University Medical Center Groningen

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-20
• Study First Submitted QC: 2011-09-22
• Study First Posted: 2011-09-23
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FES-PET	FES-PET	Patients undergo FES-PET prior to obtaining histology

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands