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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Epithelial Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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FES-PET

Patients undergo FES-PET prior to obtaining histology

Group Type EXPERIMENTAL

FES-PET

Intervention Type OTHER

Patients undergo FES-PET prior to obtaining histology

Interventions

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FES-PET

Patients undergo FES-PET prior to obtaining histology

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No