Postmenopausal Clinical Trial
Official title:
Validation of [18F]FES for Imaging of Brain Estrogen Receptors
Verified date | April 2024 |
Source | University Medical Center Groningen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Centre Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 1 year | |
Secondary | 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. |
1 year |
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