NCT00407693

Brief Summary

In this study we will examine where the radioactive tracer \[11C\]PBR28 is distributed in the body of healthy volunteers to calculate the radiation exposure to organs of the body. We will also test if \[11C\]PBR28 binds to your blood cells and compare with the binding in PET images.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 2, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2006

Completed
9.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2016

Completed
Last Updated

November 19, 2019

Status Verified

July 21, 2016

First QC Date

December 2, 2006

Last Update Submit

November 16, 2019

Conditions

Healthy

Keywords

DosimetryEffective DoseRadiation-Absorbed Dose

Outcome Measures

Primary Outcomes (1)

  • Biodistribution of [C-11]PBR28

Interventions

[C-11]PRB28DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All subjects must be healthy and aged 18-65 years.

You may not qualify if:

  • Current psychiatric disease, substance abuse or severe systemic disease based on history and physical exam.
  • Laboratory tests with clinically significant abnormalities.
  • Prior participation in other research protocols or clinical care in the last year such that radiation exposure including that from this protocol would exceed the guidelines set by the Radiation Safety Committee (RSC).
  • Pregnancy and breast feeding.
  • Positive HIV test.
  • Cannot lie flat for 2 - 3 h.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Anholt RR, De Souza EB, Oster-Granite ML, Snyder SH. Peripheral-type benzodiazepine receptors: autoradiographic localization in whole-body sections of neonatal rats. J Pharmacol Exp Ther. 1985 May;233(2):517-26.

    PMID: 2987488BACKGROUND

  • Anholt RR, Murphy KM, Mack GE, Snyder SH. Peripheral-type benzodiazepine receptors in the central nervous system: localization to olfactory nerves. J Neurosci. 1984 Feb;4(2):593-603. doi: 10.1523/JNEUROSCI.04-02-00593.1984.

    PMID: 6321699BACKGROUND

  • Anholt RR, Pedersen PL, De Souza EB, Snyder SH. The peripheral-type benzodiazepine receptor. Localization to the mitochondrial outer membrane. J Biol Chem. 1986 Jan 15;261(2):576-83.

    PMID: 3001071BACKGROUND

Study Officials

  • Masahiro Fujita, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

December 2, 2006

First Posted

December 5, 2006

Study Start

November 28, 2006

Study Completion

July 21, 2016

Last Updated

November 19, 2019

Record last verified: 2016-07-21

Locations

US(1)