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OpenTrials
Completed

NCT Number: NCT00800189

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BCCA - Vancouver Island Cancer Centre

Victoria, British Columbia, V8R 6V5, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anterior electronic portal images (EPI)

Radiation

EPI's are taken for the first three consecutive days of treatment to detect set-up errors.

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.

    Time frame: 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.

    Time frame: Will be measured on days 1, 2 and 3 of radiation therapy and possibly day 4 if adjustments of the EPI where required.

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Registry information

Official study title

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

Acronym: Anterior EPI

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Dec 2, 2008
Registry last updated
Mar 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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