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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON39348
Enrollment
14
Registered
2012-05-29
Start date
2012-12-19
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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;

Design outcomes

Primary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)