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

NCT ID: NCT00585819

Last Updated: 2012-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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2. Free breathing

Freebreathing in Body fix mold

Group Type EXPERIMENTAL

Freebreathing in Body fix mold

Intervention Type PROCEDURE

Freebreathing in Body fix mold

1. breathing cycle

reproducing breathing cycles

Group Type EXPERIMENTAL

reproduce breathing cycle utilizing spirometry

Intervention Type PROCEDURE

reproduce breathing cycle utilizing spirometry

Interventions

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reproduce breathing cycle utilizing spirometry

reproduce breathing cycle utilizing spirometry

Intervention Type PROCEDURE

Freebreathing in Body fix mold

Freebreathing in Body fix mold

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minesh Mehta

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-2007-0109

Identifier Type: -

Identifier Source: org_study_id

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