Clinical Testing of New MR Pulse Sequences

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).

Study Overview

• Status: Unknown
• Conditions: The Focus of This Study Are New Pulse Sequences.

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Frank J Rybicki, MD, PhD; Phone Number: 617-732-7206; Email: frybicki@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Frank J Rybicki, MD, PhD; Phone Number: 617-732-7206; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community sample.

Description

Inclusion Criteria:

• Healthy volunteers
• Patients undergoing clinical indicated MRI

Exclusion Criteria:

• Patients with contraindication for MRI
• Pregnant women will be excluded from this study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Scheduled for an MRI; Clinically Indicated Adults

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Frank J Rybicki, MD, PhD, Brigham and Women's Hospital

Publications and helpful links

General Publications

• Mulkern RV, Barnes AS, Haker SJ, Hung YP, Rybicki FJ, Maier SE, Tempany CM. Biexponential characterization of prostate tissue water diffusion decay curves over an extended b-factor range. Magn Reson Imaging. 2006 Jun;24(5):563-8. doi: 10.1016/j.mri.2005.12.008. Epub 2006 Feb 20.
• Ersoy H, Goldhaber SZ, Cai T, Luu T, Rosebrook J, Mulkern R, Rybicki F. Time-resolved MR angiography: a primary screening examination of patients with suspected pulmonary embolism and contraindications to administration of iodinated contrast material. AJR Am J Roentgenol. 2007 May;188(5):1246-54. doi: 10.2214/AJR.06.0901.
• McDannold N, Barnes AS, Rybicki FJ, Oshio K, Chen NK, Hynynen K, Mulkern RV. Temperature mapping considerations in the breast with line scan echo planar spectroscopic imaging. Magn Reson Med. 2007 Dec;58(6):1117-23. doi: 10.1002/mrm.21322.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: December 28, 2007
• First Submitted That Met QC Criteria: December 28, 2007
• First Posted (Estimate): January 10, 2008

Study Record Updates

• Last Update Posted (Estimate): May 15, 2012
• Last Update Submitted That Met QC Criteria: May 14, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Imaging; Spectroscopy; Magnetic Resonance
• Other Study ID Numbers: 2001-P-000545