TheranosticTrials.org

Clinical Trial · NCT01439490

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

Overview

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.

Sponsor

University Medical Center Groningen

Phase

Phase 2

Contacts

Geke AP Hospers, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01439490

Drug / Compound

fluoroestradiol

Isotope(s):
Target(s):
  • Estrogen Receptor
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Eastern Cooperative Oncology Group performance status 0-2.
  • Histological evidence or high clinical suspicion of epithelial ovarian cancer
  • The presence of at least one measurable lesion (RECIST version 1.1).
  • Postmenopausal status (defined as either \>45 years with amenorrhea \>12 months, or prior bilateral ovariectomy)
  • No history of other ER-positive malignancies
  • Able to comply with the protocol
  • Histology or cytology can be obtained (may be ascites)

Exclusion

  • Life-expectancy ≤ 3 months
  • Use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, during the 5 weeks before entry into the study