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Using Rapid Cine-MRI for Monitoring Moving and Deforming Tumors

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 March 2015 by University of Texas Southwestern Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01421784
First Posted: August 23, 2011
Last Update Posted: March 20, 2015
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):
University of Texas Southwestern Medical Center
  Purpose
In this study, the researchers investigate the feasibility of using rapid cine MR imaging to provide both offline and online soft-tissue-based image guidance. Such images will provide a significantly more complete picture of the spatial and temporal changes in thoracic anatomy. This more complete information will lay the groundwork for better radiotherapy planning and dose delivery in the presence of respiratory motion.

Condition Intervention
Lung Cancer Other: cine MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Investigating the Feasibility of Using Rapid Cine-MRI for Monitoring Moving and Deforming Tumors

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • To measure time series of MRI imaging by the b-SSFP sequence. [ Time Frame: 6 weeks ]
    To use fast acquisition sequences to obtain 2D and 3D cine MR images of moving and deforming lung tumors. The signal to noise ration (SNR) and spatiotemporal resolution of imaging sequences will be optimized into a format potentially useful for radiotherapy guidance.


Estimated Enrollment: 40
Study Start Date: September 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Procedure
Rapid Cine-MRI
Other: cine MRI
Rapid Cine-MRI for Monitoring Moving and Deforming Tumors

Detailed Description:
Rapid MRI scans from Stage I-IV non-small-cell lung cancer (NSCLC) patients will be acquired. MR acquisition will be performed without extrinsically administered contrast, using a balanced turbo field echo (TFE) sequence and commercially available coils.
  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:   No
Criteria

Inclusion Criteria:

  • AJCC Stage I, II, III or IV non-small-cell lung cancer to be treated using radiotherapy will be eligible for this study.
  • Any types and amounts of prior therapy will be allowed for this study.
  • Subjects must be greater than or equal to 18 years of age. There are no gender or ethnic restrictions.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Able to tolerate supine position
  • ECOG performance status of 3 or less

Exclusion Criteria:

  • MRI-incompatible metallic implants, embedded metallic objects, implanted biomedical devices e.g., cardiac pacemakers
  • Women who are pregnant or trying to get pregnant
  • Pain in supine position
  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): NCT01421784


Contacts
Contact: Amit Sawant, Ph.D 214-645-8525
Contact: Jean Wu, MSN 214-645-8525

Locations
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Principal Investigator: Amit Sawant, Ph.D.         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Amit Sawant, Ph.D. UT Southwestern Medical Center
  More Information

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01421784     History of Changes
Other Study ID Numbers: STU 042011-034
First Submitted: August 10, 2011
First Posted: August 23, 2011
Last Update Posted: March 20, 2015
Last Verified: March 2015