Back to resultsFES-PET to Determine ER-expression in Epithelial Ovarian Cancer
Primary Purpose
Epithelial Ovarian Cancer
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
FES-PET
Sponsored by
About this trial
This is an interventional diagnostic trial for Epithelial Ovarian Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, during the 5 weeks before entry into the study
- Life-expectancy ≤ 3 months
Sites / Locations
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FES-PET
Arm Description
Patients undergo FES-PET prior to obtaining histology
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Correlation between FES-PET and immunohistochemistry (IHC)
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
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.
Full Information
NCT ID
NCT01439490
First Posted
September 20, 2011
Last Updated
April 17, 2014
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT01439490
Brief Title
FES-PET to Determine ER-expression in Epithelial Ovarian Cancer
Official Title
Feasibility Study: FES-PET to Determine ER-expression in Epithelial Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FES-PET
Arm Type
Experimental
Arm Description
Patients undergo FES-PET prior to obtaining histology
Intervention Type
Other
Intervention Name(s)
FES-PET
Intervention Description
Patients undergo FES-PET prior to obtaining histology
Primary Outcome Measure Information:
Title
The feasibility of FES-PET to visualize and quantify ER-positive lesions in epithelial ovarian cancer.
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.
Time Frame
approximately 1 month
Secondary Outcome Measure Information:
Title
Correlation between FES-PET and immunohistochemistry (IHC)
Description
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.
Time Frame
approximately 1 month
Title
Concordance between CT-scan and FES-PET
Description
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.
Time Frame
approximately 1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, during the 5 weeks before entry into the study
Life-expectancy ≤ 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geke AP Hospers, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
19527525
Citation
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.
Results Reference
background
PubMed Identifier
18287268
Citation
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.
Results Reference
background
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FES-PET to Determine ER-expression in Epithelial Ovarian Cancer
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