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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00585819
• Other study ID #: HSC-2007-0109
• Status: Withdrawn
• Phase: N/A
• First received: December 21, 2007
• Last updated: December 30, 2011
• Start date: May 2007
• Est. completion date: December 2012

Study information

• Verified date: December 2011
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food andDrug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Lung Cancer
• Thoracic Neoplasms

Intervention

Procedure:
• reproduce breathing cycle utilizing spirometry
reproduce breathing cycle utilizing spirometry
• Freebreathing in Body fix mold
Freebreathing in Body fix mold

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproducibility of the guided breathing cycle		6 weeks	No
Secondary	Stability of motion envelope derived from initial 4D imaging compared to CT's obtained throughout the course of therapy		6 weeks	No