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

NCT01842217 | Terminated DMC

• 1 other identifier: NL41 608.042.12
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

18F-FES PET; Nuclear Medicine; Premenopausal; Postmenopausal; Estrogen receptor; Anxiety; Depression; Cognition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evalution of the levels of circulating estradiol in two patient cohorts and to evaluate the imaging technique

  1 year

Study Arms (2)

Premenopausal women

OTHER

healthy female subjects: premenopausal

Procedure: FES-PET

Postmenopausal women

OTHER

healthy female subjects: postmenopausal

Procedure: FES-PET

Interventions

FES-PET PROCEDURE

Postmenopausal women; Premenopausal women

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Age \> 18 years
• For postmenopausal women: at least 1 year after menopause
• For premenopausal women: a regular menstruation
• Signed written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Centre Groningen

Groningen, 9700RB, Netherlands

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Andor Glaudemans, MD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: April 29, 2013
• Study Start: November 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

NL (1)