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Comparing Magnetic Resonance Imaging/Spectroscopy Techniques

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00001219
Recruitment Status : Terminated (protocol has not been used for many years and has outlived it utility)
First Posted : November 4, 1999
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:

Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) are diagnostic tests that allow researchers to look at different chemical properties of tissue. Magnetic resonance imaging and spectroscopy studies can be used to gather or evaluate information about various aspects of patient s bodies or to monitor changes in the biochemistry and physiology of patient s bodies.

Unlike other diagnostic techniques (CT scan and PET scan) MRI and MRS do not use ionizing radiation. Some studies have shown that MRI is more effective at distinguishing normal parts of the anatomy from abnormal anatomy, especially in the brain. MRI has become the diagnostic test of choice for evaluating patient with multiple sclerosis.

The purpose of this study is to evaluate normal volunteers and patients with a variety of diseases with magnetic resonance imaging. Researchers will attempt different magnetic resonance imaging methods and techniques as well as different levels of magnetic strength.


Condition or disease
Abdominal Organs - Lipodystrophy Tumors

Detailed Description:

Background:

MRI is a constantly evolving imaging modality. Pulse sequences are often modified to improve their performance. However, many of these changes have not yet been approved by the FDA and therefore, are not considered standard of care. Some of these sequences require the use of new types of imaging coils, which are also investigational.

Objectives:

The major purpose of this protocol is to inform patients undergoing MR scans in the Clinical Center that they be scanned with MRI sequences and/or coils which may or may not be FDA approved and to get the patient s consent for this. This is not a formal research study since specific disease entities and specific pulse sequences are not studied in a systematic way. Rather, the purpose is to give NIH patients access to gradual improvements in MR technology that would otherwise not be available to them.

Eligibility:

All patients who, by virtue of the NIH protocol in which they are enrolled, qualify for MRI will be eligible for participation in this protocol.

Design:

Up to 99,999 participants will be enrolled in this study.

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Study Type : Observational
Actual Enrollment : 49946 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetic Resonance Imaging at 1.5 and 3.0 Tesla
Actual Study Start Date : June 18, 1987
Actual Primary Completion Date : June 3, 2020
Actual Study Completion Date : June 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Group/Cohort
Patients undergoing MRI in the Clinical Center
All patients who, by virtue of the NIH protocol in which they are enrolled, who qualify for MRI will be eligible for participation in this protocol.



Primary Outcome Measures :
  1. Success of new sequences [ Time Frame: 10 scan comparison ]
    clinically meaningful pulse sequence improvements



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:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients who by virtue of the NIH protocol in which they are enrolled who qualify for MRI in the Clinical Center, are eligible to participate if (1) Stable for MRI (2) Able to understand the consent so that consent/assent can be obtained
Criteria
  • INCLUSION CRITERIA:
  • All patients undergoing MRI in the Clinical Center.
  • Patients must be able to provide informed consents.

EXCLUSION CRITERIA:

  • Contraindications to MRI.
  • Inability to understand consent form or consent process and the absence of a suitable guardian.
  • Adults who are or may not be able to consent
  • Patients in whom the scan must be performed quickly, i.e. those patients under anesthesia, anxious patients, those requiring emergency medical care, or others in which it is deemed inappropriate to prolong a study.
  • Refusal to Participate.
  • Pregnant women and fetuses
  • Neonates

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): NCT00001219


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
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Principal Investigator: John A Butman, M.D. National Institutes of Health Clinical Center (CC)
Additional Information:
Publications:
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Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001219    
Other Study ID Numbers: 870091
87-CC-0091
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Keywords provided by National Institutes of Health Clinical Center (CC):
MR Technology
Pulse Sequences
FDA Approved
MRI Sequences
Investigational Coils
Additional relevant MeSH terms:
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Lipodystrophy
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases