Clinical trial NCT00001219: Comparing Magnetic Resonance Imaging/Spectroscopy Techniques
Official title: Magnetic Resonance Imaging at 1.5 and 3.0 Tesla
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Abdominal Organs - Lipodystrophy
Tumors
Keywords: MR Technology
Pulse Sequences
FDA Approved
MRI Sequences
Investigational Coils
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 49946
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Success of new sequences
timeFrame: 10 scan comparison
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Institutes of Health Clinical Center (CC)
name: John A Butman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Roschmann P, Tischler R. Surface coil proton MR imaging at 2 T. Radiology. 1986 Oct;161(1):251-5. doi: 10.1148/radiology.161.1.3763875.
citation: Kim EE, Pjura G, Lowry P, Verani R, Sandler C, Flechner S, Kahan B. Cyclosporin-A nephrotoxicity and acute cellular rejection in renal transplant recipients: correlation between radionuclide and histologic findings. Radiology. 1986 May;159(2):443-6. doi: 10.1148/radiology.159.2.3515421.