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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00526916
Enrollment
18
Registered
2007-09-10
Start date
2007-09-04
Completion date
2014-09-05
Last updated
2019-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurocysticercosis, Healthy

Keywords

Epilepsy, Taenia Solium, Microglia, Neuroinflammation, Compartment Model, Neurocysticercosis, Healthy Volunteer, HV

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.

Interventions

Sponsors

National Institute of Mental Health (NIMH)
Lead SponsorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* INCLUSION CRITERIA: Common to patients with neurocysticercosis and healthy subjects: Ages between 18 and 75, inclusive. 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. Presence of ferromagnetic metal in the body or heart pacemaker. ADDITIONAL

Design outcomes

Primary

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

Secondary

MeasureTime frame
MRIyears

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026