Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Using Rapid Cine-MRI for Monitoring Moving and Deforming Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center Identifier:
First received: August 10, 2011
Last updated: May 19, 2014
Last verified: May 2014

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Investigating the Feasibility of Using Rapid Cine-MRI for Monitoring Moving and Deforming Tumors

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 ] [ Designated as safety issue: No ]
    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 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01421784

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

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
Principal Investigator: Amit Sawant, Ph.D. UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center Identifier: NCT01421784     History of Changes
Other Study ID Numbers: STU 042011-034
Study First Received: August 10, 2011
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board processed this record on March 03, 2015