Evaluation of the Informational Content of Setup Verification Images for Patients Receiving Breast Radiation Therapy (Anterior EPI)
Anterior EPI
A Prospective Evaluation of the Informational Content of Setup Verification Images for Patients Receiving Breast Radiation Therapy Tangentially With or Without Supraclavicular Treatment
1 other identifier
interventional
200
1 country
1
Brief Summary
The purpose of this study is to determine if an alternative imaging protocol done at the time of radiotherapy treatments for patients with breast cancer can improve accuracy in patient set-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Aug 2008
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 28, 2008
CompletedFirst Posted
Study publicly available on registry
December 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedMarch 9, 2012
March 1, 2012
2.9 years
November 28, 2008
March 7, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
To measure the difference in accuracy of a breast imaging protocol that includes a large anterior EPI in detecting set-up errors outside of tolerance as compared to the current standard breast imaging protocols.
Will be measured on days 1, 2 and 3 of radiation therapy and possibly day 4 if adjustments of the EPI where required.
Secondary Outcomes (1)
What effect does the addition of a larger anterior EPI have on detection of setup errors in the medial/lateral, anterior/posterior, or superior/inferior directions and at what frequency do these errors occur in clinical practice.
Will be measured on days 1, 2 and 3 of radiation therapy and possibly day 4 if adjustments of the EPI where required.
Interventions
EPI's are taken for the first three consecutive days of treatment to detect set-up errors.
Eligibility Criteria
You may qualify if:
- All patients (male or female) receiving tangential breast/chest wall radiotherapy only, or three or four field breast/chest wall and nodal radiotherapy will be eligible.
You may not qualify if:
- Those patients receiving partial breast treatment, those patients requiring an electron match field, those on another breast cancer radiotherapy trial, those who require radiotherapy using deep inspiration breath hold or multi-field intensity modulated radiotherapy, and all non-breast cancer patients will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BCCA - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elaine Wai
British Columbia Cancer Agency
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 28, 2008
First Posted
December 2, 2008
Study Start
August 1, 2008
Primary Completion
July 1, 2011
Study Completion
August 1, 2011
Last Updated
March 9, 2012
Record last verified: 2012-03