Clinical trial NCT01439490: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epithelial Ovarian Cancer
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2011-09-23
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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. 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

Primary outcomes:
measure: The feasibility of FES-PET to visualize and quantify ER-positive lesions in epithelial ovarian cancer.
timeFrame: approximately 1 month
Secondary outcomes:
measure: Correlation between FES-PET and immunohistochemistry (IHC)
timeFrame: approximately 1 month
measure: Concordance between CT-scan and FES-PET
timeFrame: approximately 1 month
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Geke AP Hospers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.