PET Imaging of Noradrenergic Transmission in the Brain
Background:
Researchers have developed a new radioactive tracer (11C-ARMI). A tracer is a drug that attaches itself to other chemicals in the body and lights up so that the chemicals can be seen in imaging scans. The new tracer may be able to help them with many diseases, such as Alzheimer s disease and Parkinson s disease. Researchers want to test the new tracer in healthy people.
Objective:
To test a new tracer (11C-ARMI) during imaging scans of the brain and body in healthy people.
Eligibility:
Healthy people aged 18 years and older. They must have been screened under protocols 01-M-0254 or 17M0181.
Design:
All participants will have a positron emission tomography (PET)/computed tomography (CT) scan. Before the scan, they will have blood and urine tests and a test of their heart function. The tracer will be given through a tube attached to a needle inserted into a vein in the arm. They will lie on a padded bed that fits inside a doughnut-shaped machine; the machine uses x-rays to create images of the inside of the body.
Some participants will have a PET/CT scan of their whole body. They will need only 1 visit.
Some participants will have a PET/CT scan of only their brain. They will have up to 2 visits. On the second visit, they will have a magnetic resonance imaging (MRI) scan of the brain. For the MRI, they will lie on a table that slides into a cylinder. The MRI uses magnetic fields to create images of the inside of the body.
Participants will receive a follow-up call to check on their well-being after their PET/CT scans.
Studieoversikt
Detaljert beskrivelse
Study Description:
This study is intended to provide information on the novel 11C-ARMI radioligand and its ability to localize and measure Alpha-1A Adrenoreceptor (alpha-1A AR) in the brain and body of healthy volunteers.
Objectives:
Primary Objective:
To study the brain uptake of 11C-ARMI and perform kinetic modeling of 11C-ARMI in healthy volunteers.
Secondary Objectives:
To study brain retest variability and reliability, biodistribution, and dosimetry of 11C-ARMI in healthy volunteers.
Endpoint:
Primary Endpoint:
For both objectives, the primary endpoint is receptor density measured as distribution volume (VT).
Secondary Endpoint:
Radiation burden to the body and expressed as Effective Dose (ED).
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Robert B Innis, M.D.
- Telefonnummer: (301) 594-1368
- E-post: robert.innis@nih.gov
Studer Kontakt Backup
- Navn: Tara N Turon, C.R.N.P.
- Telefonnummer: (301) 827-6599
- E-post: tara.turon@nih.gov
Studiesteder
-
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Maryland
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Bethesda, Maryland, Forente stater, 20892
- Rekruttering
- National Institutes of Health Clinical Center
-
Ta kontakt med:
- NIH Clinical Center Office of Patient Recruitment (OPR)
- Telefonnummer: TTY dial 711 800-411-1222
- E-post: ccopr@nih.gov
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
INCLUSION CRITERIA:
- Aged 18 years or older.
- Must have undergone a screening assessment under protocol 01-M-0254, The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants or 17M0181 Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies.
- Be healthy based on medical history, physical examination, and laboratory testing.
- Able to understand and willingness to provide informed consent.
- Willingness to complete all study procedures including MRI tests.
- Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.
- Agree to adhere to the lifestyle considerations
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).
- Recent exposure to radiation (i.e., PET from other research) that, when combined with this study, would be above the allowable limits.
- Inability to lie flat on camera bed for at least two hours, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).
- HIV infection.
- Pregnancy or breastfeeding.
- Must not have substance use disorder or alcohol use disorder.
- Unable to travel to the NIH.
- Unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.
- Taking medications reported to have significant binding to alpha-1 adrenoceptors, medications that that alter norepinephrine release, or medications that lower blood pressure including antihypertensives, diuretics, or phosphodiesterase-5(PDE-5) inhibitors (e.g. sildenafil, tadalafil, vardenafil) within five elimination halflives prior to any [11C]ARMI PET scan.
- Known hypersensitivity to quinazoline-class medications (e.g., prazosin), defined as any prior allergic or clinically significant adverse reaction requiring discontinuation or medical evaluation.
- Blood donation within 8 weeks (2 months) before study participation, or unwillingness to avoid blood donation for 8 weeks (2 months) after the study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: En arm
Alle forsøkspersoner vil motta de samme testene.
|
Injected IV followed by PET scanning
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
To measure distribution volume
Tidsramme: 24 months
|
Target quantification
|
24 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To measure variability distribution volume
Tidsramme: 24 months
|
24 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Robert B Innis, M.D., National Institute of Mental Health (NIMH)
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 10002497
- 002497-M
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
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