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Validation of a Novel Thoracic Neoplasm Radiotherapy Image Guidance Technique: A Pilot Study

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ClinicalTrials.gov Identifier: NCT00585819
Recruitment Status : Withdrawn (lack of interest)
First Posted : January 3, 2008
Last Update Posted : January 4, 2012
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The overall, broad objective of this study is to pilot the BSD technique. The specific purpose of this particular study is to generate pilot data to validate several crucial steps of the BSD technique, in particular steps 1, 2, and 4. Radiation treatments will proceed per standard of care, and will not be modified in any way during this protocol. This study is a non-treatment protocol.

Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: reproduce breathing cycle utilizing spirometry Procedure: Freebreathing in Body fix mold Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Validation of a Novel Thoracic Neoplasm Radiotherapy Image Guidance Technique: A Pilot Study
Study Start Date : May 2007
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 2. Free breathing
Freebreathing in Body fix mold
Procedure: Freebreathing in Body fix mold
Freebreathing in Body fix mold

Experimental: 1. breathing cycle
reproducing breathing cycles
Procedure: reproduce breathing cycle utilizing spirometry
reproduce breathing cycle utilizing spirometry




Primary Outcome Measures :
  1. Reproducibility of the guided breathing cycle [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Stability of motion envelope derived from initial 4D imaging compared to CT's obtained throughout the course of therapy [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any thoracic neoplasm scheduled to undergo radiation therapy
  • 18 years or older
  • Must be treated with radiation as part of standard of care
  • Able to tolerate the mouthpiece for spirometry and video glasses
  • Ability to provide written informed consent

Exclusion Criteria:


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): NCT00585819


Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Minesh Mehta University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00585819     History of Changes
Other Study ID Numbers: HSC-2007-0109
First Posted: January 3, 2008    Key Record Dates
Last Update Posted: January 4, 2012
Last Verified: December 2011

Additional relevant MeSH terms:
Neoplasms
Thoracic Neoplasms
Neoplasms by Site