Evaluation of the Informational Content of Setup Verification Images for Patients Receiving Breast Radiation Therapy (Anterior EPI)

Breast Cancer Clinical Trial

— Anterior EPI  

Official title:

A Prospective Evaluation of the Informational Content of Setup Verification Images for Patients Receiving Breast Radiation Therapy Tangentially With or Without Supraclavicular Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800189
• Other study ID #: BCCA002
• Status: Completed
• Phase: N/A
• First received: November 28, 2008
• Last updated: March 7, 2012
• Start date: August 2008
• Est. completion date: August 2011

Study information

• Verified date: March 2012
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Accurate patient positioning is critical in Radiation Therapy. Electronic imaging is used to compare a patient's actual treatment position, with that which was planned from an initial CT scan. Radiation Therapists compare planned and actual images using analysis software to determine if differences are within acceptable tolerances. At the VIC, we use 3 different breast imaging protocols depending on the patient set-up and treatment technique. Findings from our recent retrospective planning study show that our current electronic imaging protocols miss some clinically significant patient set-up errors, particularly in the medial/lateral direction, and that these errors can be better detected with the use of an anterior image. The purpose of this study is to test these findings prospectively in clinical practice, through the direct comparison of our current protocols with a proposed new protocol, which would include an anterior electronic portal image (EPI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Radiation:
• Anterior electronic portal images (EPI)
EPI's are taken for the first three consecutive days of treatment to detect set-up errors.

Locations

Country	Name	City	State
Canada	BCCA - Vancouver Island Cancer Centre	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
British Columbia Cancer Agency

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	Yes