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Clinical Trials/NCT00526916
NCT00526916
Completed
Phase 1

PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [C-11]PBR28

National Institute of Mental Health (NIMH)1 site in 1 country18 target enrollmentSeptember 4, 2007

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Neurocysticercosis
Sponsor
National Institute of Mental Health (NIMH)
Enrollment
18
Locations
1
Primary Endpoint
Binding of [C-11]PBR28 at peripheral benzodiazepine receptors
Status
Completed
Last Updated
6 years ago

Overview

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.

Detailed Description

Objective In endemic regions neurocysticercosis is the most common cause of adult acquired epilepsy and thus an important public health problem. The disease is caused by infection with the larval form of the tapeworm, Taenia solium. Although neurocysticercosis is common only in many developing regions, an increased number of patients are diagnosed in developed countries mostly due to immigration of infected individuals. The peripheral benzodiazepine receptor (PBR) can be a clinically useful marker to detect neuroinflammation because activated microglia in inflammatory areas expresses much greater levels of PBR than in microglia in resting conditions. PBR has been imaged with positron emission tomography (PET) using \[(11)C\]1-(2-chlorophenyl-N-methylpropyl)-3-isoquinoline carboxamide (PK11195), which provides low levels of specific signal. Recently we developed a new ligand, \[(11)C\]N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine (PBR28), which showed much greater specific signal than \[(11)C\]PK11195 in non-human primates. The major objective of this protocol is to assess the utility of \[(11)C\]PBR28 PET to detect neuroinflammation in patients with neurocysticercosis. Study population Thirty patients will be recruited and clinically followed under protocol 85-I-0127, Treatment of Cysticercosis including Neurocysticercosis with Praziquantel or Albendazole, (PI: Theodore E. Nash, MD, NIAID). Thirty healthy subjects will be recruited. Design Fifteen patients with neurocysticercosis and the first 15 age-matched healthy subjects will have brain PET scans. Patients will have up to three \[(11)C\]PBR28 PET scans during the follow-up and the treatment under 85-I-0127, typically a few weeks apart. Outcome measures PBR28 binding will be compared with clinical symptoms and MRI findings. In addition, the binding will be compared between patients and age-matched control subjects because the high levels of specific binding may allow detection of an increase of PBR in regions where MRI does not detect inflammation.

Registry
clinicaltrials.gov
Start Date
September 4, 2007
End Date
September 5, 2014
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Binding of [C-11]PBR28 at peripheral benzodiazepine receptors

Secondary Outcomes

  • MRI(years)

Study Sites (1)

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