Imaging Techniques in MRI

Background:

- Magnetic resonance imaging (MRI) scans must be performed according to specified sets of parameters that provide optimal images of each organ and each area of the body. These scanning parameters are often specific to the institution or organization at which they are employed, and may also depend on the manufacturer of the MRI scanning equipment. Because MRI scanning equipment is always being updated and upgraded, researchers are interested in developing new and optimized scanning parameters for MRI scans.

Objectives:

- To improve current methods and develop new techniques for magnetic resonance imaging.

Eligibility:

  • Individuals 18 years of age and older who are either volunteers or current NIH protocol participants.
  • Participants must not have any medical history factors (e.g., extreme claustrophobia, history of metal implants) that would prevent them from receiving MRI scans.

Design:

  • Participants will have at least one MRI scan that will last from 20 minutes to 2 hours (most scans will last between 45 and 90 minutes). The total time commitment for most visits will be approximately 4 hours from start to finish.
  • Some MRI techniques require standard monitoring equipment or specific procedures during the scanning, such as an electrocardiogram.
  • Participants will have blood samples taken at the time of the scan. Some MRI studies will require the use of a contrast agent that will be administered during the scan.
  • Volunteers may be asked to return for additional MRI scans over the course of a few years. Follow-up scans may be done on the same part of the body or on different parts of the body. No more than one MRI scan will be performed in any 4-week period for this protocol.

Study Overview

Status

Recruiting

Detailed Description

Magnetic Resonance (MR) Imaging performed on volunteers will be used to develop and optimize techniques useful in the advancement of MRI technology.

The results will be used to evaluate the performance of new imaging methods and equipment on human subjects, and to provide essential ground work for research and development for use in future patients. MR imaging is a non invasive technology, though some scans, dependent on imaging area and researcher preference, may be performed with MR contrast -- gadolinium (Gd) --given intravenously.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Recruiting
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Volunteers (maybe Volunteers, NIH employee and current NIH protocol participants)

Description

  • INCLUSION CRITERIA:

A. Volunteer individuals

B. Lab Eligibility parameters (for contrast scans with in 4 weeks of gadolinium injection):

  • Creatinine below upper normal limit
  • eGFR greater than or equal to 60 mL/min/1.73m(2)

    • Age greater than or equal to 60 or history of renal disease: test GFR within 1 week prior to contrast

C. Willing to travel to the NIH for follow-up visits.

D. Greater than or equal to 18 years old

E. Able to understand and sign informed consent

F. No MRI scan with gadolinium injection in the last 6 months under this protocol.

EXCLUSION CRITERIA:

A. Implanted metal clips or wires of the type which may concentrate radiofrequency fields or cause tissue damages from twisting in a Magnetic field. Examples:

  • Aneurysm clip, implanted neural stimulator,
  • Implanted cardiac pacemaker, defibrillator, or certain other implanted electrical or metallic devices,
  • Cochlear implant, ocular foreign body (metal shavings),
  • Any implanted device (pumps, infusion devices, etc.),
  • Shrapnel injuries,
  • History of metal in head or eyes or other parts of the body.

B. Pregnant women

C. Paralyzed hemidiaphragm

D. Over 500 lbs and/or a body circumference that prevents the study subject from laying flat in the scanner

E. Surgery of uncertain type

F. Untreatable claustrophobia otherwise requiring anesthesia.

G. Any contraindications that the Physician identifies from the subject, MRI Safety Questionnaire, and/or History and Physical.

EXCLUSION FOR PARTICIPATION FOR GADOLINIUM CONTRAST:

(Inclusive of the above exclusion criteria):

A. Allergy to gadolinium for scans using contrast; will be eligible for non-contrast scans.

B. Acute renal failure, renal transplant, dialysis and renal failure individuals (eGFR <60 mL/min/1.73m(2) and/or clinically diagnosed).

C. Individuals with a history of liver transplant or severe liver disease.

D. Lactating women

E. Individuals with hemoglobinopathies or severe asthma.

F. Patient preference to not undergo intravenous line placement and/or receive gadolinium contrast. Contrast administration is optional and participants may still undergo a non-contrast study.

G. GBCA with an MRI scan in the last 6 months. This includes scan performed with GBCA at any outside institution and/or at the clinical center .In addition, they cannot have reached their maximum of 4 GBCA imaging studies under this protocol. They will be excluded from having a contrast enhanced MRI, but will not be excluded from the protocol for non-contrast MRI studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Volunteers
Volunteers (maybe Volunteers, NIH employee and current NIH protocol participants)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To refine current methodology and develop new techniques for MRI
Time Frame: End of study
To refine current methodology and develop new techniques for magnetic resonance imaging in the general population.
End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ashkan A Malayeri, M.D., National Institutes of Health Clinical Center (CC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2010

Study Registration Dates

First Submitted

May 25, 2010

First Submitted That Met QC Criteria

May 25, 2010

First Posted (Estimated)

May 26, 2010

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

September 12, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 100115
  • 10-CC-0115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

.We are working on deciding if we want to share IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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