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

Phase 2
18 Years
Open (Enrolling)
Epithelial Ovarian Cancer

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Trial Information

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

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. ECOG 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Outcome Measure:

The feasibility of FES-PET to visualize and quantify ER-positive lesions in epithelial ovarian cancer.

Outcome Description:

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.

Outcome Time Frame:

approximately 1 month

Safety Issue:


Principal Investigator

Geke AP Hospers, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Centre Groningen


Netherlands: Medical Ethics Review Committee (METC)

Study ID:




Start Date:

August 2011

Completion Date:

February 2014

Related Keywords:

  • Epithelial Ovarian Cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial