Clinical trial NCT01842217: Validation of [18F]FES for Imaging of Brain Estrogen Receptors
Official title: Validation of [18F]FES for Imaging of Brain Estrogen Receptors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Psychiatric/Mood Disorder | Patient
Estrogen Receptor Levels
Premenopausal
Postmenopausal
Keywords: 18F-FES PET
Nuclear Medicine
Premenopausal
Postmenopausal
Estrogen receptor
Anxiety
Depression
Cognition
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2013-04-29
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Validation of \[18F\]-FES for imaging of estrogen receptors in the brain

The primary objective of the study is to determine if \[18F\]-FES Positron Emission Tomography (PET) can be used to quantify the estrogen receptor expression in the human brain.

Detailed description: Estrogens are the primary female sex hormones that play a major role in the development and maintenance of secondary sexual functions. In addition, estrogens play an important role in cardiovascular, musculoskeletal, immunological, bone development and central nervous system processes. Actions of estrogens are mediated by a group of specialized receptors, known as estrogen receptors. Estrogens were found to be neuroprotective and may thus protect against development of neurodegenerative disorders like Alzheimer's disease, Parkinson's disease and multiple sclerosis. In addition, estrogens may also play an important role in psychiatric disorders, like depression. To improve our understanding of the action of estrogens in the brain, it is important to study the expression of estrogen receptors in the brain. Positron emission tomography (PET) is the most suitable technique for non-invasive imaging of brain receptors. \[18F\]FES is a PET tracer that is regularly used in the UMCG to image the estrogen receptor expression in breast cancer patients, but has never been used for quantitative imaging of brain estrogen receptors. Quantification of the expression of brain receptors by PET usually requires arterial blood sampling to obtain the plasma input function of the tracer. Arterial blood sampling causes discomfort to the patient and therefore can be an obstacle especially in longitudinal studies. The aim of this study is therefore to investigate whether \[18F\]FES PET imaging for quantification of estrogen receptors in the human brain is feasible without arterial blood sampling, using a reference tissue model (SRTM) or an image derived input function (IDIF), so the discomfort associated with arterial blood sampling can be avoided.

Eligibility criteria: 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, such as tamoxifen or fulvestrant
* History of ER-positive malignancies or breast cancer
* Use of any contraceptive drugs (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 diseases
* Major metabolic diseases (e.g. diabetes, hyper- or hypothyroidism)
* 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, like: pacemaker, metallic implants/prostheses, metal fragments, shunts, artificial heart valves, vascular clips, fixed hearing aid, tattoos containing metal, hair implants, artificial dentures

Primary outcomes:
measure: Quantification of estrogen receptors in the human brain
timeFrame: 1 year
Secondary outcomes:
measure: Evalution of the levels of circulating estradiol in two patient cohorts and to evaluate the imaging technique
timeFrame: 1 year
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Andor Glaudemans, MD
role: PRINCIPAL_INVESTIGATOR
References: