- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00407693
PET Whole Body Imaging Using a Peripheral Benzodiazepine Receptor Ligand [C-11]PBR28
Studieoversigt
Detaljeret beskrivelse
The peripheral benzodiazepine receptor (PBR) is distinct from central benzodiazepine receptors associated with GABA(A) receptors. Although PBR was initially identified in peripheral organs such as kidneys, endocrine glands and lungs, later studies identified PBR in the central nervous system. In normal conditions, PBR is expressed in low levels in some neurons and glial cells. PBR can be a clinically useful marker to detect neuroinflammation because activated microglial cells in inflammatory areas express much greater levels of PBR than in microglial cells in resting conditions.
PBR has been imaged with positron emission tomography (PET) using [(11)C]1-(2-chlorophenyl-N-methylpropyl)-3-isoquinoline carboxamide (PK11195). However, this classical ligand provides only low levels of specific signals and is not sensitive to detect changes that occurred in vivo. Recently we developed a new ligand, N-acetyl-N-(2-[(11)C]methoxybenzyl)-2-phenoxy-5-pyridinamine [(11)C]PBR28), which showed much greater specific signals than [(11)C]PK11195 in non-human primates. Therefore, [(11)C]PBR28 is a promising PET ligand. However, radiation absorbed doses have not been estimated from human whole body imaging.
The initial purpose of this protocol is to estimate radiation absorbed doses of [11C]PBR28 by performing whole body imaging studies on ten healthy human subjects. The radiation absorbed doses are required to apply this PET ligand in various neurological and psychiatric disorders in the future.
Under the current and other protocols using [(11)C]PBR28, we found that some healthy subjects and patients have very low to no binding of [(11)C]PBR28. We studied approximately 188 subjects in total under protocols using [11C]PBR28 and found that 8.5% (16/188) had almost no binding of [(11)C]PBR28. Several published ligands have been tested and all of the tested ligands recently developed show low affinity to a subset of humans. By using [(11)C]PBR28, we need to exclude PBR28 nonbinders from the data to study changes in PBR. By using a PET ligand that binds equally to PBR28 binders and nonbinders, we would be able to study all subjects. We also confirmed that PBR28 nonbinders determined by PET do not show binding in in vitro binding assays using blood cells.
We wish to test new ligands currently being developed in our chemistry group by obtaining blood samples from additional PBR28 nonbinders (= low affinity binders) and by performing in vitro binding assays. Because our preliminary analysis of whole body imaging has shown that the differences between PBR28 binders and nonbinders might somewhat vary among organs and the cause of the nonbinding phenomenon is not fully understood, after identifying PBR28 nonbinders by binding assays, we will perform whole body imaging using [(11)C]PBR28.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Maryland
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Bethesda, Maryland, Forenede Stater, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
- INCLUSION CRITERIA:
All subjects must be healthy and aged 18-65 years.
EXCLUSION CRITERIA:
- Current psychiatric disease, substance abuse or severe systemic disease based on history and physical exam.
- Laboratory tests with clinically significant abnormalities.
- Prior participation in other research protocols or clinical care in the last year such that radiation exposure including that from this protocol would exceed the guidelines set by the Radiation Safety Committee (RSC).
- Pregnancy and breast feeding.
- Positive HIV test.
- Cannot lie flat for 2 - 3 h.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Biodistribution of [C-11]PBR28
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- 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. doi: 10.1523/JNEUROSCI.04-02-00593.1984.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 070035
- 07-M-0035
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Kliniske forsøg med [C-11]PRB28
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Jennifer WhitwellNational Institute on Aging (NIA)RekrutteringCorticobasal degeneration | Corticobasalt syndrom | Corticobasal degeneration (CBD) | Corticobasalt syndrom (CBS) | Corticobasal Syndrom (CBS) | Cortico Basal DegenerationForenede Stater
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Yale UniversityNational Institute on Drug Abuse (NIDA); National Institutes of Health...Aktiv, ikke rekrutterende
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Yale UniversityNational Institute on Drug Abuse (NIDA)AfsluttetSund og rask | Cannabis afhængighedForenede Stater
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National Institute of Mental Health (NIMH)AfsluttetSund og rask | ÅreforkalkningForenede Stater
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Brigham and Women's HospitalRekrutteringMultipel scleroseForenede Stater
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National Institute of Mental Health (NIMH)AfsluttetSund og rask | NeurocysticercosisForenede Stater
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National Institute of Neurological Disorders and...AfsluttetMultipel scleroseForenede Stater
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National Cancer Institute (NCI)AfsluttetProstatakræftForenede Stater
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National Institute of Mental Health (NIMH)Afsluttet
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National Institute of Mental Health (NIMH)National Institute of Mental Health, Eli Lilly & Co.AfsluttetSund og raskForenede Stater