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

This study is currently recruiting participants.

Verified by University of Wisconsin, Madison, June 2008

First Received: December 21, 2007 Last Updated: June 2, 2008 History of Changes

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00585819

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:	Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
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 Radiation Therapy

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 motieon 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 ]

Estimated Enrollment:	20
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2. Free breathing: Experimental Freebreathing in Body fix mold	Procedure: Freebreathing in Body fix mold Freebreathing in Body fix mold
1. breathing cycle: Experimental 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

Contacts

Contact: Cancer Connect

608-622-8922

Locations

United States, Wisconsin
University of Wisconsin Hospital and Clinics	Recruiting
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 Comprehensive Cancer Center ( MineshMehta )
Study ID Numbers:	HSC-2007-0109
Study First Received:	December 21, 2007
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00585819 History of Changes
Health Authority:	United States: Food andDrug Administration

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on September 10, 2009