Completed

PET Whole Body Biodistribution and Test Retest Brain Imaging Studies Using a Dopamine Transporter Ligand [18F]FECNT

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What is being tested

Data Collection

Who is being recruted

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2004Actual date on which the first participant was enrolled.

The dopamine system plays important roles in various neurological and psychiatric disorders such as Parkinson's disease, schizophrenia, mood disorders, and attention-deficit hyperactivity disorder. Several positron emission tomography (PET) and single photon emission computed topography (SPECT) tracers have been developed including \[11C\]CFT and \[123I\]beta-CIT. These tracers have been successfully applied in patients, particularly to stage those with Parkinson's disease. However, these tracers lack selectivity among monoamine (dopamine, serotonin, and norepinephrine) transporters. Recently a new PET tracer, \[18F\]FECNT brain uptake and washout has been developed, which has high selectivity and affinity to the dopamine transporter (DAT). Part 1 of this study will measure the kinetics of \[18F\]FECNT brain uptake and washout. Part 2 will estimate radiation-absorbed doses in healthy human subjects by performing whole body PET imaging studies. Part 3 will assess the reliability of measuring DAT densities in the brain by performing a test retest brain PET studies in healthy human subjects. The results of this overall study are required to apply this tracer in various neurological and psychiatric disorders in the future.

Official TitlePET Whole Body Biodistribution and Test Retest Brain Imaging Studies Using a Dopamine Transporter Ligand [18F]FECNT 
NCT00083629
Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
30 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Criteria

INCLUSION CRITERIA: Healthy subjects ages 18-65 EXCLUSION CRITERIA-WHOLE BODY IMAGING: Current diagnosis of psychiatric disease, substance dependence or severe systemic disease. History of substance abuse within 6 months. Abnormal laboratory tests. Prior participation in other research protocols within the past year such that a radiation exposure together with the present study would exceed the annual limits. Pregnancy and breast feeding. HIV positive. EXCLUSION CRITERIA-DYNAMIC BRAIN IMAGING: Current diagnosis of psychiatric disease, substance dependence or severe systemic disease. History of substance abuse within 6 months. Abnormal laboratory tests. Novocain allergy. Prior participation in other research protocols within the past year such that a radiation exposure together with the present study would exceed the annual limits. Any condition that increases increase risk for MRI (e.g., pacemaker, metallic foreign body in the eye). Pregnancy and breast feeding. HIV positive.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
National Institute of Mental Health (NIMH)Bethesda, United StatesSee the location
CompletedOne Study Center