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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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00585819
First received: December 21, 2007
Last updated: December 30, 2011
Last verified: December 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Validation of a Novel Thoracic Neoplasm Radiotherapy Image Guidance Technique: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • Reproducibility of the guided breathing cycle [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00585819     History of Changes
Other Study ID Numbers: HSC-2007-0109
Study First Received: December 21, 2007
Last Updated: December 30, 2011
Health Authority: United States: Food andDrug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013