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

Epithelial Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439490
• Other study ID #: RUG2011-0704
• Status: Completed
• Phase: Phase 2
• Start date: August 2011
• Est. completion date: February 2014

Study information

• Verified date: May 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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. Eastern Cooperative Oncology Group 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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• FES-PET
Patients undergo FES-PET prior to obtaining histology

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	approximately 1 month
Secondary	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.	approximately 1 month