Validation of a Novel Thoracic Neoplasm Radiotherapy Imag... | NCT00585819

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

NCT00585819

Sponsor

University of Wisconsin, Madison

Status

Withdrawn

Last Update Posted

Jan 4, 2012Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Lung Cancer

Interventions

reproduce breathing cycle utilizing spirometry
Freebreathing in Body fix mold

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of interest

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Dec 21, 2007

First Submission Date that Met QC Criteria

Dec 21, 2007

First Posted Date

Jan 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2011

Last Update Posted Date

Jan 4, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
reproduce breathing cycle utilizing spirometry	Procedure	reproduce breathing cycle utilizing spirometry	1. breathing cycle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reproducibility of the guided breathing cycle		6 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Minesh Mehta	University of Wisconsin, Madison	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin Hospital and Clinics		Madison	Wisconsin	53792	United States

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided