Psychiatric/Mood Disorder | PatientNCT01842217
Validation of [18F]FES for Imaging of Brain Estrogen Receptors
A study testing FES-PET in people with Psychiatric/Mood Disorder | Patient and Estrogen Receptor Levels, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychiatric/Mood Disorder | Patient, Estrogen Receptor Levels, Premenopausal
- What is being tested?
- FES-PET
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2013to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Age > 18 years
- For postmenopausal women: at least 1 year after menopause
- For premenopausal women: a regular menstruation
- Signed written informed consent
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Psychiatric/Mood Disorder | Patient, Estrogen Receptor Levels, Premenopausal, Postmenopausal
- Being tested
- FES-PET
- Keywords
- 18F-FES PET, Nuclear Medicine, Premenopausal, Postmenopausal, Estrogen receptor, Anxiety, Depression, Cognition
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES-PETProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Premenopausal women | Other | healthy female subjects: premenopausal Receives: Procedure: FES-PET |
| Postmenopausal women | Other | healthy female subjects: postmenopausal Receives: Procedure: FES-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of estrogen receptors in the human brain
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 ERs in the human brain, by [18F]FES PET, using pharmacokinetic modelling with arterial sampling as golden standard
Measured: 1 year
Secondary outcomes (1)
Evalution of the levels of circulating estradiol in two patient cohorts and to evaluate the imaging technique
- To evaluate the effect of the levels of circulating estradiol on quantification of ERs in the human brain, by comparing premenopausal women with postmenopausal women.
- To investigate whether PET acquisition time can be shortened to reduce the subjects discomfort, as the current protocol requires the patient to be scanned for 90 min.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Not enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric/Mood Disorder | PatientStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andor Glaudemans, MD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842217
- Sponsor's protocol ID
- NL41 608.042.12
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2013
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of [18F]FES for Imaging of Brain Estrogen Receptors
- ClinicalTrials.gov ID
- NCT01842217
- Acronym / sponsor ID
- NL41 608.042.12
- Conditions
- Psychiatric/Mood Disorder | Patient, Estrogen Receptor Levels, Premenopausal, Postmenopausal
- Keywords
- 18F-FES PET, Nuclear Medicine, Premenopausal, Postmenopausal, Estrogen receptor, Anxiety, Depression, Cognition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough participants
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premenopausal women | Other | Procedure: FES-PEThealthy female subjects: premenopausal |
| Postmenopausal women | Other | Procedure: FES-PEThealthy female subjects: postmenopausal |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- Age > 18 years
- For postmenopausal women: at least 1 year after menopause
- For premenopausal women: a regular menstruation
- Signed written informed consent
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FES-PET | Procedure or surgery | Postmenopausal women, Premenopausal women |
Primary outcome
Quantification of estrogen receptors in the human brain
Time frame: 1 year
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 ERs in the human brain, by [18F]FES PET, using pharmacokinetic modelling with arterial sampling as golden standard
1 secondary outcome
Evalution of the levels of circulating estradiol in two patient cohorts and to evaluate the imaging technique
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Not enough participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andor Glaudemans, MD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES-PET in people with Psychiatric/Mood Disorder | Patient and Estrogen Receptor Levels, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enough participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of estrogen receptors in the human brain (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.