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Clinical Testing of New MR Pulse Sequences

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Frank John Rybicki, MD, PhD, Brigham and Women's Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00590252
First Posted: January 10, 2008
Last Update Posted: May 15, 2012
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.
Information provided by (Responsible Party):
Frank John Rybicki, MD, PhD, Brigham and Women's Hospital
  Purpose
To test and validate newly developed magnetic resonance (MR) pulse sequences for their ability to enhance the collection of morphological, biomedical, and functional information from the human body. To test clinical protocols on the various MR systems available at Brigham and Women's Hospital (BWH).

Condition
The Focus of This Study Are New Pulse Sequences.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Testing of New MR Pulse Sequences

Further study details as provided by Frank John Rybicki, MD, PhD, Brigham and Women's Hospital:

Biospecimen Retention:   None Retained
There are no biospecimens

Estimated Enrollment: 500
Study Start Date: July 2007
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Scheduled for an MRI
Clinically Indicated Adults

Detailed Description:

Magnetic resonance (MR) scanners use computer software, called pulse sequences, to extract different types of information from the human body. Though MR has largely matured to become a routine clinical imaging modality, substantial development is still underway in order to fully exploit the technology. BWH Radiology has been a leader in pulse sequence development and the protocol under review has played a large part in this development over the last several years.

The importance of further development in MR cannot be understated. In particular, biochemical information, detailed properties of water diffusion and perfusion in tissue, cardiac imaging, and high-resolution brain imaging, all hold great potential for improving medical diagnosis and monitoring.

MR pulse sequence software is typically developed in small incremental steps. For example, an investigator may receive a new state of the art sequence from the manufacturer of the scanner equipment. (S)he may then decide to add flow-sensitizing gradients. This process is not straightforward, but requires extensive testing, first in phantoms and then in-vivo, to determine if the pulse sequence is capable of performing the new task and, moreover, to see if the new feature does not introduce undesired artifacts.

Some modifications, like the introduction diffusion-sensitizing gradients, must be tested in patients, since changes of tissue diffusion can only be observed in stroke victims. Once the researcher attained the first goal, (s)he may proceed with other modifications, e.g., modifications which will improve the temporal resolution. The completion of a new sequence, which ultimately may be used in a large normal subject or patient study, may involve a large number of design steps, where each step must be tested in one or a few subjects before development proceeds. Another scenario is the application of an existing patient protocol to different, existing, and FDA approved equipment. For example the need may arise to use a different radiofrequency coil (surface coil instead of head coil) or a scanner system with different magnetic field strength (3.0 Tesla instead of 1.5 Tesla). Several parameters, such as signal-to-noise ratio, or T1 and T2 weighting may change under such circumstances. In most cases only a study in a subject will reveal if protocol parameter settings are adequate. Therefore, this protocol is different from a conventional study, where exactly the same protocol will be applied to each of a large number of subjects. However, the protocol and the general procedures of data handling used during the different scans is similar enough, so it can be summarized into a general development protocol.

The purpose of this protocol is to test and validate newly developed MR pulse sequences.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample.
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Patients undergoing clinical indicated MRI

Exclusion Criteria:

  • Patients with contraindication for MRI
  • Pregnant women will be excluded from this study
  Contacts and Locations
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): NCT00590252


Contacts
Contact: Frank J Rybicki, MD, PhD 617-732-7206 frybicki@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Frank J Rybicki, MD, PhD    617-732-7206    frybicki@partners.org   
Sub-Investigator: Jill M Goldstein, PhD         
Sub-Investigator: Hiroto Hatabu, MD, PhD         
Sub-Investigator: Ference Jolesz, MD         
Sub-Investigator: Marek R Kubicki, MD         
Sub-Investigator: Bruno Madore, MD         
Sub-Investigator: Nathan J McDannold, PhD         
Sub-Investigator: Dimitrios Mitsouras, PhD         
Sub-Investigator: Lawrence Panych, PhD         
Sub-Investigator: Eva Gombos, MD         
Sub-Investigator: Clare Tempany-Afdhal, MD         
Sub-Investigator: Gary P Zientara, PhD         
Sub-Investigator: Ehud Schmidt, PhD         
Sub-Investigator: Nehal Shah, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Frank J Rybicki, MD, PhD Brigham and Women's Hospital