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

This study is currently recruiting participants.
Verified January 2013 by University Medical Centre Groningen
Sponsor:
Information provided by (Responsible Party):
G.A.P. Hospers, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01439490
First received: September 20, 2011
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Epithelial Ovarian Cancer
 Other: Diagnostic intervention: Positron Emission Tomography with 16-alpha-[18-fluoro]-17betaestradiol
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Feasibility Study: FES-PET to Determine ER-expression in Epithelial Ovarian Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • The feasibility of FES-PET to visualize and quantify ER-positive lesions in epithelial ovarian cancer. [ Time Frame: approximately 1 month ] [ Designated as safety issue: No ]
    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:
  • Correlation between FES-PET and immunohistochemistry (IHC) [ Time Frame: approximately 1 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: approximately 1 month ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 16
Study Start Date: August 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epithelial ovarian cancer
Postmenopausal patients with histological evidence of epithelial ovarian cancer, or high clinical clinical suspicion (with proven malignant ascites) and high probability of epithelial ovarian cancer will undergo FES-PET examination. Both patients with primary ovarian cancer as well as patients with advanced or recurrent disease are eligible.
 Other: Diagnostic intervention: Positron Emission Tomography with 16-alpha-[18-fluoro]-17betaestradiol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439490

Contacts
Contact: Geke AP Hospers, MD, PhD +31 50 3616161 g.a.p.hospers@int.umcg.nl

Locations
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands
Contact: Geke AP Hospers, MD, PhD     +31 50 3616161     g.a.p.hospers@int.umcg.nl    
Contact: E GE de Vries, MD, PhD     +31 50 3616161     e.g.e.de.vries@int.umcg.nl    
Principal Investigator: Geke AP Hospers, MD, PhD            
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: Geke AP Hospers, MD, PhD University Medical Centre Groningen
  More Information

Publications:

Responsible Party: G.A.P. Hospers, Principal investigator, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01439490     History of Changes
Other Study ID Numbers: RUG2011-0704
Study First Received: September 20, 2011
Last Updated: January 17, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Estradiol
 Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on May 21, 2013