Comparing Magnetic Resonance Imaging/Spectroscopy Techniques

Tumors Clinical Trial

Official title:

Magnetic Resonance Imaging at 1.5 and 3.0 Tesla

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00001219
• Other study ID #: 870091
• Secondary ID: 87-CC-0091
• Status: Terminated
• Start date: June 18, 1987
• Est. completion date: June 3, 2020

Study information

• Verified date: June 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49946
• Est. completion date: June 3, 2020
• Est. primary completion date: June 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 99 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Abdominal Organs - Lipodystrophy
• Lipodystrophy
• Tumors

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Frank JA, Dwyer AJ, Doppman JL. Nuclear magnetic resonance imaging in oncology. Important Adv Oncol. 1987:133-74. Review. — View 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. — View Citation

Röschmann P, Tischler R. Surface coil proton MR imaging at 2 T. Radiology. 1986 Oct;161(1):251-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of new sequences	clinically meaningful pulse sequence improvements	10 scan comparison

External Links

•   NIH Clinical Center Detailed Web Page