Validation of [18F]FES for Imaging of Brain Estrogen Receptors

NCT ID: NCT01842217

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-01-31

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.

Conditions

Psychiatric/Mood Disorder | Patient; Estrogen Receptor Levels; Premenopausal; Postmenopausal

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Premenopausal women

healthy female subjects: premenopausal

Group Type: OTHER

FES-PET

Intervention Type: PROCEDURE

Postmenopausal women

healthy female subjects: postmenopausal

Group Type: OTHER

FES-PET

Intervention Type: PROCEDURE

Interventions

FES-PET

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andor Glaudemans, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Centre Groningen

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

NL41 608.042.12

Identifier Type: -

Identifier Source: org_study_id