NCT01439490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

2.5 years

First QC Date

September 20, 2011

Last Update Submit

May 3, 2024

Conditions

Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

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

    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.

    approximately 1 month

Secondary Outcomes (2)

  • Correlation between FES-PET and immunohistochemistry (IHC)

    approximately 1 month

  • Concordance between CT-scan and FES-PET

    approximately 1 month

Study Arms (1)

FES-PET

EXPERIMENTAL

Patients undergo FES-PET prior to obtaining histology

Other: FES-PET

Interventions

FES-PETOTHER

Patients undergo FES-PET prior to obtaining histology

FES-PET

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

Location

Related Publications (2)

  • Yoshida Y, Kurokawa T, Tsujikawa T, Okazawa H, Kotsuji F. Positron emission tomography in ovarian cancer: 18F-deoxy-glucose and 16alpha-18F-fluoro-17beta-estradiol PET. J Ovarian Res. 2009 Jun 16;2(1):7. doi: 10.1186/1757-2215-2-7.

    PMID: 19527525BACKGROUND

  • Peterson LM, Mankoff DA, Lawton T, Yagle K, Schubert EK, Stekhova S, Gown A, Link JM, Tewson T, Krohn KA. Quantitative imaging of estrogen receptor expression in breast cancer with PET and 18F-fluoroestradiol. J Nucl Med. 2008 Mar;49(3):367-74. doi: 10.2967/jnumed.107.047506. Epub 2008 Feb 20.

    PMID: 18287268BACKGROUND

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Geke AP Hospers, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2011

First Posted

September 23, 2011

Study Start

August 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

May 6, 2024

Record last verified: 2024-05

Locations

NL(1)