Validation of [18F]FES for imaging of brain estrogen receptors

Completed

• Conditions: gezonde deelnemers; healthy controls

• Registration Number: NL-OMON37068
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

- Female
- Age > 18 years
- For postmenopausal women: at least 1 year after menopause
- For premenopausal women: a regular menstruation
- Signed written informed consent

Exclusion Criteria

- Use of estrogen receptor ligands
- History of ER-positive malignancies or breast cancer
- Use of any contraceptive drug (pill, injections or implanted)
- For postmenopausal women: (history of) estrogen replacement therapy
- Pregnancy
- History of removal of the ovaries and/or the uterus
- Current systemic and or major metabolic diseases
- Somatic, organic or neurological disorders
- Recent participation in a scientific research study (<1 year) involving radiation
- Claustrophobia
- Presence of materials in the body that can be magnetized

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are the binding potential and distribution volume of<br /><br>[18F]FES in the human brain, derived from kinetic modelling using an arterial<br /><br>input function, reference tissue modelling and an image derived input function.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A secondary study parameter is the level of estradiol in serum.</p><br>