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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00585819

Enrollment

Registered

2008-01-03

Start date

2007-05-31

Completion date

2012-12-31

Last updated

2012-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Interventions

PROCEDUREreproduce breathing cycle utilizing spirometry

reproduce breathing cycle utilizing spirometry

PROCEDUREFreebreathing in Body fix mold

Freebreathing in Body fix mold

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Reproducibility of the guided breathing cycle	6 weeks

Secondary

Measure	Time frame
Stability of motion envelope derived from initial 4D imaging compared to CT's obtained throughout the course of therapy	6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026