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

April 16, 2024 updated by: University Medical Center Groningen

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700RB
        • University Medical Centre Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Premenopausal women
healthy female subjects: premenopausal
Procedure: FES-PET
Other: Postmenopausal women
healthy female subjects: postmenopausal
Procedure: FES-PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evalution of the levels of circulating estradiol in two patient cohorts and to evaluate the imaging technique
Time Frame: 1 year
  1. 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.
  2. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Andor Glaudemans, MD, University Medical Center Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 24, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (Estimated)

April 29, 2013

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL41 608.042.12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postmenopausal

Clinical Trials on FES-PET

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe