Clinical trial NCT01324206: Development of 3T Magnetic Resonance Research Methods for NIA Studies
Official title: Development of Magnetic Resonance Imaging and Spectroscopy Research Methods for NIA Studies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Normal Physiology
Keywords: Magnetic Resonance Imaging
Healthy Volunteers
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2011-03-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers, male and female, 18yrs and older

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: * 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.

Primary outcomes:
measure: Develop and refine scanning procedures
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: National Institute of Aging, Clinical Research Unit
state: Maryland
Study officials:
affiliation: National Institute on Aging (NIA)
name: Mustapha Bouhrara, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: