The primary objective of the study is to validate the use of a reference tissue model and an image derived input function for the quantification of estrogen receptors in the human brain, by [18F]FES PET. The secondary objective is to determine…
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Brief title
Condition
- Other condition
Synonym
Health condition
gezonde deelnemers
Research involving
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Outcome measures
Primary outcome
The main study parameters are the binding potential and distribution volume of
[18F]FES in the human brain, derived from kinetic modelling using an arterial
input function, reference tissue modelling and an image derived input function.
Secondary outcome
A secondary study parameter is the level of estradiol in serum.
Background summary
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 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.
Study objective
The primary objective of the study is to validate the use of a reference tissue
model and an image derived input function for the quantification of estrogen
receptors in the human brain, by [18F]FES PET. The secondary objective is to
determine whether circulating estradiol can influence quantification of
estrogen receptors by [18F]FES.
Study design
Healthy pre- and postmenopausal women will be included for a dynamic [18F]FES
PET scan and a MRI scan, with a maximum of one week between the PET and MRI
scan. During the PET scan arterial blood samples will be taken as input for
quantification of the estrogen receptors in the brain, using kinetic modelling.
This golden standard quantification method will be compared with two methods
that do not require blood sampling, i.e. reference tissue modelling and kinetic
modelling using an image derived input function. In addition, serum estradiol
levels will be measured to determine the effect of circulating estradiol on
quantification of the estrogen receptors.
Study burden and risks
The subjects have to fill in a questionnaire and undergo a PET and a MRI scan.
A total of 85 ml of blood will be taken for determination of serum levels of
estradiol and for PET scan data-analysis. For the PET scan, the arterial
catheterization can cause discomfort and the subjects are exposed to
radioactivity with minor to moderate risk. The subjects will not obtain direct
benefit from the study but will contribute to determining the best method for
quantification of the estrogen receptor in the human brain and consequently to
a reduction of discomfort for subjects that undergo a [18F]FES PET scans in
future studies, if arterial blood sampling can be omitted.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-003472-39-NL |
| CCMO | NL41608.042.12 |