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

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00585819
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Duration (Months): 67.1
• Patients Per Site Per Month: 0

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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 1, 2007
• Anticipated Primary Completion Date: Dec 1, 2012
• Anticipated Study Completion Date: Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Reproducibility of the guided breathing cycle [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 [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00585819
• Other Study ID Numbers: HSC-2007-0109
• First Posted: Jan 3, 2008
• Last Update Posted: Jan 4, 2012
• Last Verified: Dec 1, 2011

• Additional relevant MeSH terms: Neoplasms; Thoracic Neoplasms

Study Results

No Results Posted as of Jan 4, 2012