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New Magnetic Resonance Imaging and Spectroscopy Software in the Improvement of Image Quality

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ClinicalTrials.gov Identifier: NCT03980535
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This trial studies how well new magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI) software works in improving the image quality of scans in both patients and healthy volunteers. Improving the image quality of MRI and MRSI through new software may lead to implementation of these techniques and better clinical care for patients.

Condition or disease Intervention/treatment Phase
Health Status Unknown Healthy Subject Procedure: Magnetic Resonance Imaging Procedure: Magnetic Resonance Spectroscopic Imaging Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To help develop and/or optimize new magnetic resonance (MR) imaging and spectroscopy applications and analysis software in order to provide the best MR services for the investigator's patients.

OUTLINE:

Patients undergo an additional investigational MRI or MRSI sequence along with the standard MRI or MRSI. Healthy volunteers undergo an investigational MRI or MRSI sequence. Healthy volunteers may also undergo an additional standard sequence if there is one that can be compared to the investigational sequence. All MRI or MRSI procedures, including the standard MRI or MRSI, are no longer than 60 minutes.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Evaluation of New Magnetic Resonance (MR) Imaging and Spectroscopy Software
Actual Study Start Date : April 16, 2012
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Device Feasibility (MRI, MRSI)
Patients undergo an additional investigational MRI or MRSI sequence along with the standard MRI or MRSI. Healthy volunteers undergo an investigational MRI or MRSI sequence. Healthy volunteers may also undergo an additional standard sequence if there is one that can be compared to the investigational sequence. All MRI or MRSI procedures, including the standard MRI or MRSI, are no longer than 60 minutes.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

Procedure: Magnetic Resonance Spectroscopic Imaging
Undergo MRSI
Other Names:
  • 1H- Nuclear Magnetic Resonance Spectroscopic Imaging
  • 1H-nuclear magnetic resonance spectroscopic imaging
  • Magnetic Resonance Spectroscopy
  • MRS
  • MRS Imaging
  • MRSI
  • Proton Magnetic Resonance Spectroscopic Imaging




Primary Outcome Measures :
  1. Development and/or optimization of new magnetic resonance (MR) imaging and spectroscopy applications and analysis software [ Time Frame: Up to 7 years ]
    A set of images will be collected using the new magnetic resonance imaging (MRI) or MR spectroscopy techniques. Whenever appropriate, another set of images using the standard of care software will also be collected and this set of images by the standard of care software will be compared to the images that are collected with the new MRI or MR spectroscopy techniques.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients who are scheduled for routine MR imaging or spectroscopy examinations at MD Anderson Cancer Center (MDACC).
  • Written informed consent will be obtained from each subject scanned who enrolled to individual sub-project under this protocol.

Exclusion Criteria:

  • No pregnant subjects will be enrolled
  • No investigational devices or drugs will be used.
  • No contraindications to MR exam(s)
  • No contraindications to MR exam(s) using the same screening process utilized for MDACC patients (DI Patient Record - Part I, MR Screening section)
  • Healthy volunteers (including healthy MD Anderson employee volunteers) under the direct report of a sub-project principal investigator (PI) will be excluded for that specific sub-project.

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): NCT03980535


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: John Madewell    713-792-4973      
Principal Investigator: John Madewell         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: John Madewell M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03980535     History of Changes
Other Study ID Numbers: 2011-0542
NCI-2019-02654 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2011-0542 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No