NCT00527579

Brief Summary

The purpose of this protocol is to measure peripheral benzodiazepine receptors in the brain using positron emission tomography (PET) and compare the imaging results between patients and healthy people.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_1

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

September 4, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2007

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2013

Completed
Last Updated

July 5, 2018

Status Verified

November 26, 2013

Enrollment Period

6.2 years

First QC Date

September 8, 2007

Last Update Submit

July 3, 2018

Conditions

NeurocysticercosisHealthy

Keywords

EpilepsyTaenia SoliumMicrogliaNeuroinflammationCompartment ModelNeurocysticercosisHealthy VolunteerHV

Outcome Measures

Primary Outcomes (1)

  • Binding of [F-18]FBR at peripheral benzodiazepine receptor.

    3 years

Secondary Outcomes (1)

  • MRI

    3 years

Interventions

[F-18]FBRDRUG

Eligibility Criteria

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

You may qualify if:

  • COMMON TO PATIENTS WITH NEUROCYSTICERCOSIS AND HEALTHY SUBJECTS:
  • Ages between 18 and 65, inclusive.
  • \<TAB\>
  • Control subjects are healthy based on history, physical exams, ECG, and lab tests.

You may not qualify if:

  • COMMON TO ALL SUBJECTS:
  • Current psychiatric illness, substance abuse or severe systemic disease based on history and physical exam.
  • ECG with clinically significant abnormalities. Any existing physical exam and ECG within one year will be reviewed and if none already exists in the chart, these will be obtained and reviewed.
  • Prior participation in other research protocols or clinical care in the last year such that radiation exposure would exceed the annual guideline of RSC.
  • Pregnancy or breast feeding.
  • Claustrophobia.
  • Positive HIV test.
  • Cannot lie on back for a few hours for the PET scans.
  • Presence of ferromagnetic metal in the body or heart pacemaker.
  • \[(18)F\]FBR did not show binding in a whole body PET \[(18)F\]FBR scan in the past.
  • Medically unstable.
  • Seizures are not well controlled with medications.
  • A history of brain disease other than neurocysticercosis.
  • Laboratory tests with clinically significant abnormalities unrelated to neurocysticercosis or its treatment.
  • Laboratory tests with clinically significant abnormalities.
  • +1 more criteria

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

MeSH Terms

Conditions

NeurocysticercosisEpilepsyTaeniasisNeuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Central Nervous System HelminthiasisCentral Nervous System Parasitic InfectionsCentral Nervous System InfectionsInfectionsParasitic DiseasesCysticercosisCestode InfectionsHelminthiasisCentral Nervous System DiseasesNervous System DiseasesBrain DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

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
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2007

First Posted

September 11, 2007

Study Start

September 4, 2007

Primary Completion

November 26, 2013

Study Completion

November 26, 2013

Last Updated

July 5, 2018

Record last verified: 2013-11-26

Locations

US(1)