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Imaging Techniques in MRI

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01130545
First received: May 25, 2010
Last updated: November 11, 2014
Last verified: June 2014
  Purpose

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.

Condition
Magnetic Resonance Imaging

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Imaging Techniques in MRI

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1000
Study Start Date: May 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

A. Volunteers and current NIH protocol participants are eligible

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

  • Creatinine within normal limits
  • Blood Urea Nitrogen within normal limits
  • 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

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130545

Contacts
Contact: Jerina L Tinsley (301) 496-7700 lshae.tinsley@nih.gov
Contact: David A Bluemke, M.D. (301) 402-1854 bluemked@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: David A Bluemke, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01130545     History of Changes
Other Study ID Numbers: 100115, 10-CC-0115
Study First Received: May 25, 2010
Last Updated: November 11, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Magnetic Resonance Imaging
Gadolinium
Healthy Volunteer
HV

ClinicalTrials.gov processed this record on November 24, 2014