Development of 3T Magnetic Resonance Research Methods for NIA Studies

Development of Magnetic Resonance Imaging and Spectroscopy Research Methods for NIA Studies

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.

Study Overview

• Status: Recruiting
• Conditions: Normal Physiology

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Sarah Park, R.N.; Phone Number: (410) 350-7315; Email: sarah.park@nih.gov
• Study Contact Backup: Name: Mustapha Bouhrara, Ph.D.; Phone Number: (410) 558-8541; Email: bouhraram@mail.nih.gov

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • National Institute of Aging, Clinical Research Unit
      • Contact: NIA Studies Recruitment; Phone Number: 410-350-3941; Email: niastudiesrecruitment@mail.nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Healthy volunteers, male and female, 18yrs and older

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy Volunteers; Healthy Volunteers, 18 or older years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Develop and refine scanning procedures	To develop and refine specific imaging and spectroscopic methods.	2 months

Collaborators and Investigators

• Sponsor: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Mustapha Bouhrara, Ph.D., National Institute on Aging (NIA)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2008

Study Registration Dates

• First Submitted: March 25, 2011
• First Submitted That Met QC Criteria: March 25, 2011
• First Posted (Estimated): March 28, 2011

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 16, 2024

More Information

Terms related to this study

• Keywords: Natural History; Healthy Volunteers; Magnetic Resonance Imaging
• Other Study ID Numbers: 080238; 08-AG-0238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: .There is ongoing discussion within the NIA IRP and a plan has not been finalized yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No