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.
Studie Overzicht
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Robert B Innis, M.D.
- Telefoonnummer: (301) 594-1368
- E-mail: robert.innis@nih.gov
Studie Contact Back-up
- Naam: Tara N Turon, C.R.N.P.
- Telefoonnummer: (301) 827-6599
- E-mail: tara.turon@nih.gov
Studie Locaties
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Maryland
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Bethesda, Maryland, Verenigde Staten, 20892
- Werving
- National Institutes of Health Clinical Center
-
Contact:
- NIH Clinical Center Office of Patient Recruitment (OPR)
- Telefoonnummer: TTY dial 711 800-411-1222
- E-mail: ccopr@nih.gov
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: Eenmal
Alle onderwerpen ontvangen dezelfde tests.
|
Injected IV followed by PET scanning
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
To measure distribution volume
Tijdsspanne: 24 months
|
Target quantification
|
24 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
To measure variability distribution volume
Tijdsspanne: 24 months
|
24 months
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Robert B Innis, M.D., National Institute of Mental Health (NIMH)
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 10002497
- 002497-M
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
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