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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00527579 |
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 I Phase II |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study |
| Official Title: | PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [F-18]FBR |
| Estimated Enrollment: | 55 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
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| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| Responsible Party: | National Institutes of Health ( Robert B. Innis, M.D./National Institute of Mental Health ) |
| Study ID Numbers: | 070209, 07-M-0209 |
| Study First Received: | September 8, 2007 |
| Last Updated: | October 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00527579 History of Changes |
| Health Authority: | United States: Federal Government |
|
Epilepsy Taenia Solium Microglia Neuroinflammation |
Compartment Model Neurocysticercosis Health Volunteer HV |
|
Central Nervous System Infections Central Nervous System Helminthiasis Nervous System Diseases Central Nervous System Diseases Cysticercosis Parasitic Diseases |
Taeniasis Cestode Infections Neurocysticercosis Helminthiasis Central Nervous System Parasitic Infections |
