PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [F-18]FB

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

ClinicalTrials.gov Identifier:

NCT00527579

First received: September 8, 2007

Last updated: May 1, 2013

Last verified: November 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Neurocysticercosis Healthy	Drug: [F-18]FBR	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [F-18]FBR

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:

Binding of [F-18]FBR at peripheral benzodiazepine receptor. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

MRI [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	September 2007
Study Completion Date:	January 2012

Intervention Details:

N/A

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

COMMON TO PATIENTS WITH NEUROCYSTICERCOSIS AND HEALTHY SUBJECTS:

Ages between 18 and 65, inclusive.

In addition, patients must meet the inclusion criteria of protocol 85-I-0127.

Control subjects are healthy based on history, physical exams, ECG, and lab tests.

EXCLUSION CRITERIA:

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.

ADDITIONAL EXCLUSION CRITERIA TO BRAIN 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.

ADDITIONAL EXCLUSION CRITERIA FOR PATIENTS:

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.

ADDITIONAL EXCLUSION CRITERIA FOR HEALTHY SUBJECTS:

Laboratory tests with clinically significant abnormalities.

A history of brain disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527579

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Masahiro Fujita, M.D.

National Institute of Mental Health (NIMH)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

Responsible Party:	National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:	NCT00527579 History of Changes
Other Study ID Numbers:	070209, 07-M-0209
Study First Received:	September 8, 2007
Last Updated:	May 1, 2013
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Epilepsy
Taenia Solium
Microglia
Neuroinflammation

Compartment Model
Neurocysticercosis
Healthy Volunteer
HV

Additional relevant MeSH terms:

Neurocysticercosis
Cysticercosis
Taeniasis
Central Nervous System Helminthiasis
Central Nervous System Parasitic Infections
Parasitic Diseases

Cestode Infections
Helminthiasis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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