NCT00585819

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2007

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 3, 2008

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 4, 2012

Status Verified

December 1, 2011

Enrollment Period

5.6 years

First QC Date

December 21, 2007

Last Update Submit

December 30, 2011

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Reproducibility of the guided breathing cycle

    6 weeks

Secondary Outcomes (1)

  • Stability of motion envelope derived from initial 4D imaging compared to CT's obtained throughout the course of therapy

    6 weeks

Study Arms (2)

2. Free breathing

EXPERIMENTAL

Freebreathing in Body fix mold

Procedure: Freebreathing in Body fix mold

1. breathing cycle

EXPERIMENTAL

reproducing breathing cycles

Procedure: reproduce breathing cycle utilizing spirometry

Interventions

reproduce breathing cycle utilizing spirometryPROCEDURE

reproduce breathing cycle utilizing spirometry

1. breathing cycle
Freebreathing in Body fix moldPROCEDURE

Freebreathing in Body fix mold

2. Free breathing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any thoracic neoplasm scheduled to undergo radiation therapy
  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Minesh Mehta

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 3, 2008

Study Start

May 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 4, 2012

Record last verified: 2011-12

Locations

US(1)