Validation of novel PET tracer [11C]-GMOM: Assessment of dosimetry, biodistribution, and specific binding in healthy volunteers

Completed

• Conditions: onderzoek heeft in de toekomst betrekking op bovenstaande aandoeningen, maar wordt uitgevoerd bij gezonde controles; NMDA receptor function (not a specific disease); 10029305; 10039628

• Registration Number: NL-OMON39348
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

- Men and women;
- Age between 18-40 years;
- Good physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests (Haemoglobin (Hb) must be 8 mmol \ litre at the time of the screening for males and 7 mmol \ litre for females);
- Weight 50 kg;
- Never mentally ill according to Research Diagnostic Criteria (RDC);
- A negative pregnancy test must be obtained for all females within 48 hours before starting the PET scan;- Normal MRI scan as evaluated by a neuroradiologist;
- Written informed consent of the subject;

Exclusion Criteria

- (History of) Any psychiatric or neurological disorder (DSM-IV criteria);
- Coronary heart disease;
- (History of) Alcohol and/or drug abuse (DSM-IV criteria);
- Any clinical significant abnormality of any clinical laboratory test, including drug screening;
- Any condition that may interfere with MRI scanning, e.g. metal objects in or around the body or claustrophobia;
- Blood donation or substantial blood loss within 3 months before the PET scan;
- Intake of investigational medication within 30 days prior to the start of this study;
- Pregnancy;
- Smoking;

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objectives:<br /><br>i) To examine the regional brain uptake and its metabolites of [11C]GMOM in<br /><br>healthy volunteers.<br /><br>ii) To examine the specific binding potential of [11C]GMOM in the brain in<br /><br>healthy volunteers before and after ketamine displacement<br /><br>iii) To assess the whole body biodistribution and to determine the dosimetry of<br /><br>[11C]GMOM in healthy volunteers.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>