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- Klinische proef NCT01324206
Ontwikkeling van 3T magnetische resonantie-onderzoeksmethoden voor NIA-onderzoeken
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Mustapha Bouhrara, Ph.D.
- Telefoonnummer: (410) 558-8541
- E-mail: bouhraram@mail.nih.gov
Studie Contact Back-up
- Naam: Seung-Ho Park, R.N.
- Telefoonnummer: (410) 350-7315
- E-mail: sarah.park@nih.gov
Studie Locaties
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-
Maryland
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Baltimore, Maryland, Verenigde Staten, 21224
- Werving
- National Institute of Aging, Clinical Research Unit
-
Contact:
- NIA Studies Recruitment
- Telefoonnummer: 410-350-3941
- E-mail: niastudiesrecruitment@mail.nih.gov
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Healthy volunteers, male and female, 18yrs and older
Beschrijving
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: CASE_ONLY
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
|---|
|
Healthy Volunteers
Healthy Volunteers, 18 or older years |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Develop and refine scanning procedures
Tijdsspanne: 2 months
|
To develop and refine specific imaging and spectroscopic methods. |
2 months
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Mustapha Bouhrara, Ph.D., National Institute on Aging (NIA)
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Geschat)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 080238
- 08-AG-0238
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
There is ongoing discussion within the NIA IRP and a plan has not been finalized yet.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .