- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01324206
Udvikling af 3T magnetisk resonansforskningsmetoder til NIA-studier
Background:
- Magnetic resonance imaging (MRI) studies provide important information on the structure and function of various body systems, including the brain, muscles, joints, heart, and blood vessels. Scientific applications of MRI scans often use techniques that need to be modified or refined before they are used in clinical studies. To develop and modify these techniques for the new Philips 3T Achieva whole-body MRI scanner, researchers are interested in conducting trial MRI scans on healthy individuals and individuals with conditions that require imaging studies.
Objectives:
- To conduct preliminary trials of the 3T MRI facility to develop and refine MRI scanning procedures.
Eligibility:
- Individuals at least 18 years of age who are able to have magnetic resonance imaging.
Design:
- Participants will be screened with a full medical history and physical examination, as well as blood and urine tests.
- Participants will have an MRI scan using the 3T scanner. Some scans may require the use of a contrast agent or radiotracer, which is a small amount of radioactive substance that will be injected before the start of the scan. Some participants may be asked to perform tasks of thinking and movement while in the scanner, in order to test the procedures required for a functional MRI scan.
- No treatment will be provided as part of this protocol.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Study Description:
The purpose of this protocol is to permit use of the magnetic resonance imaging (MRI) facility for the development and refinement of MRI and spectroscopy (MRIS) scanning procedures. The information obtained through these methodological assessments will be essential future clinical research investigations conducted through the NIA under specific protocols. Additionally, this data can be utilized in already approved NIA studies for comparison purposes.
Objectives:
Primary Objective: To develop and refine specific MR imaging and spectroscopy methods.
Secondary Objectives: To allow pilot tests of procedures for development and refinement of motor or cognitive activation paradigms.
Endpoints:
Development of noninvasive MR biomarkers to assess longevity, healthy longevity, physical disability, cognitive impairment, and frailty.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Mustapha Bouhrara, Ph.D.
- Telefonnummer: (410) 558-8541
- E-mail: bouhraram@mail.nih.gov
Undersøgelse Kontakt Backup
- Navn: Seung-Ho Park, R.N.
- Telefonnummer: (410) 350-7315
- E-mail: sarah.park@nih.gov
Studiesteder
-
-
Maryland
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Baltimore, Maryland, Forenede Stater, 21224
- Rekruttering
- National Institute of Aging, Clinical Research Unit
-
Kontakt:
- NIA Studies Recruitment
- Telefonnummer: 410-350-3941
- E-mail: niastudiesrecruitment@mail.nih.gov
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Healthy volunteers, male and female, 18yrs and older
Beskrivelse
- INCLUSION CRITERIA:
To be eligible to participate in this study, an individual must meet all the following criteria:
- Ability of subject to understand the study and stated willingness to comply with all study procedures.
- Male or female, age > 18years.
- Able to speak and read English.
- Capable of providing informed consent.
- Subjects or persons identified by an investigator to have a condition of interest for exploratory studies as it relates to aging. These participants are not being scanned for diagnostic purposes.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Has condition and/or non-removable device contraindicated for MRI as per the MRI eligibility form.
- Weight > 300lbs (MRI scanner weight limit)
- Is currently pregnant or a nursing mother.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: CASE_ONLY
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Healthy Volunteers
Healthy Volunteers, 18 or older years |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Develop and refine scanning procedures
Tidsramme: 2 months
|
To develop and refine specific imaging and spectroscopic methods. |
2 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Mustapha Bouhrara, Ph.D., National Institute on Aging (NIA)
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 080238
- 08-AG-0238
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
There is ongoing discussion within the NIA IRP and a plan has not been finalized yet.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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