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Imaging of hormonal characteristics of ovarian cancer by means of positron emission tomography.

Feasibility Study: FES-PET to determine ER-expression in epithelial ovarian cancer

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-001429-25-NL
Enrollment
Unknown
Registered
2011-06-16
Start date
2011-08-23
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

epithelial ovarian cancer

Interventions

Product Name: 16-alpha-[18F]-17-beta-estradiol Product Code: 18F-FES Pharmaceutical Form: Solution for injection

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histological evidence or high clinical suspicion with proven malignant ascites and high probability of epithelial ovarian cancer 2. The presence of at least one measurable lesion (RECIST v1.1). 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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Main Objective: The feasibility of FES-PET to visualize and quantify ER-positive lesions in epithelial ovarian cancer.;Secondary Objective: To correlate FES-PET results to CT-scan and immunohistochemistry for ER isoforms.;Primary end point(s): This is a feasibility/ pilot study: to visualize and quantify ER-positive lesions in epithelial ovarian cancer. ;Timepoint(s) of evaluation of this end point: For each patient, the tumor tracer uptake will be calculated after the PET scan is performed.—

Secondary

MeasureTime frame
Secondary end point(s): - To correlate FES-PET results to CT-scan and immunohistochemistry for ER isoforms. ;Timepoint(s) of evaluation of this end point: After the inclusion of all patients; after ~1-2 years—

Countries

Netherlands

Contacts

Public ContactDep. Med. Oncology

University Medical Center Groningen

g.a.p.hospers@int.umcg.nl+31503616161

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026