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

Status Terminated

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01842217
Study type	Interventional
Source	University Medical Center Groningen
Contact
Status	Terminated
Phase	N/A
Start date	November 2013
Completion date	January 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.