NCT00001714

Brief Summary

This project will measure magnetization transfer (MT) parameters on normal subjects using two novel approaches. The first is the investigation of asymmetric MT effects with respect to the zero or on-resonance reference point. The technique measures the difference in MT effect between two symmetrically positioned off-resonance MT pulses in the positive and negative frequency ranges. Prior research with this technique in the kidney show a difference in the macromolecular lineshape that correlates to a specific metabolite. The second approach, utilizing a subset of the acquisitions from the first approach, will test newly developed formulation to calculate the macromolecular fraction, or fraction of proton density that accounts for MT. We foresee these measurements may significantly develop our understanding of MT and introduce diagnostic and quantitative tools to study human tissues.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 1998

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2001

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

February 1, 2001

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

MRIMacromoleculesMagnetization TransferMetabolitesTissue CharacterizationNormal Volunteer

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Normal control between the ages of 18 - 70 years of age who are capable of giving informed consent. Subjects must not have a condition which would preclude their use for technical development (e.g. paralyzed hemidiaphragm, morbid obesity, claustrophobia, etc.). Subjects must not have a condition which would present unnecessary risks (e.g. pregnancy, surgery of uncertain type, symptoms of pheochromocystoma or insulinoma, etc.). Lactating women and subjects with hemoglobinopathies, asthma, or renal or hepatic disease will be excluded from studies involving the administration of contrast agents. Must not have a contraindication to MR scanning such as surgery that involves metal clips or wires which might be expected to concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field. Examples include: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or autodefibrillator; cochlear implant; ocular foreign body (e.g. metal shavings); insulin pump.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren G. Magnuson Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Bottomley PA, Foster TH, Argersinger RE, Pfeifer LM. A review of normal tissue hydrogen NMR relaxation times and relaxation mechanisms from 1-100 MHz: dependence on tissue type, NMR frequency, temperature, species, excision, and age. Med Phys. 1984 Jul-Aug;11(4):425-48. doi: 10.1118/1.595535.

    PMID: 6482839BACKGROUND
  • Wolff SD, Balaban RS. Magnetization transfer contrast (MTC) and tissue water proton relaxation in vivo. Magn Reson Med. 1989 Apr;10(1):135-44. doi: 10.1002/mrm.1910100113.

    PMID: 2547135BACKGROUND
  • Wolff SD, Balaban RS. Magnetization transfer imaging: practical aspects and clinical applications. Radiology. 1994 Sep;192(3):593-9. doi: 10.1148/radiology.192.3.8058919. No abstract available.

    PMID: 8058919BACKGROUND

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

March 1, 1998

Study Completion

July 1, 2001

Last Updated

March 4, 2008

Record last verified: 2001-02

Locations