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Imaging Techniques in MRI

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ClinicalTrials.gov Identifier: NCT01130545
Recruitment Status : Recruiting
First Posted : May 26, 2010
Last Update Posted : January 19, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:

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 or disease
Cardiac Risk Factors Healthy Healthy Volunteers

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Imaging Techniques in MRI
Actual Study Start Date : June 5, 2010

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Volunteers (maybe Volunteers, NIH employee and current NIH protocol participants)
Criteria
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130545


Contacts
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Contact: Tracy L Cropper, R.N. (301) 402-6132 tcropper@cc.nih.gov
Contact: Ashkan A Malayeri, M.D. (301) 451-4368 ashkan.malayeri@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
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Principal Investigator: Ashkan A Malayeri, M.D. National Institutes of Health Clinical Center (CC)
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01130545    
Other Study ID Numbers: 100115
10-CC-0115
First Posted: May 26, 2010    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: August 9, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: .We are working on deciding if we want to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC):
Healthy Volunteer
Magnetic Resonance Imaging
Gadolinium
Natural History
HV