We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been withdrawn prior to enrollment.
(lack of interest)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00585819
First Posted: January 3, 2008
Last Update Posted: January 4, 2012
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 Wisconsin, Madison
  Purpose
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 Intervention
Lung Cancer Procedure: reproduce breathing cycle utilizing spirometry Procedure: Freebreathing in Body fix mold

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

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

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

Enrollment: 0
Study Start Date: May 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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:

  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): 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
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00585819     History of Changes
Other Study ID Numbers: HSC-2007-0109
First Submitted: December 21, 2007
First Posted: January 3, 2008
Last Update Posted: January 4, 2012
Last Verified: December 2011

Additional relevant MeSH terms:
Neoplasms
Thoracic Neoplasms
Neoplasms by Site