Can 3D Ultrasound Be Used Reproducibly by Radiation Therapists in Partial Breast Image-Guided Radiation Therapy (IGRT)
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|ClinicalTrials.gov Identifier: NCT00911456|
Recruitment Status : Completed
First Posted : June 2, 2009
Last Update Posted : February 17, 2012
|Condition or disease||Intervention/treatment||Phase|
|Radiation Therapy for Primary Breast Cancer||Procedure: Image-Guided Radiation Therapy using 3D Ultrasound Guided-Therapy Procedure: Ultrasound Guided Imaging Procedure: 3 DUS||Phase 3|
TB Contouring The CT1, CT2, and US1 tumor beds will be manually contoured on the RM workstation by one of the study radiation therapists. Contouring will be performed using previously defined contouring guidelines. Available automatic contouring tools, including the 'interpolate' contouring function, may be utilized and contouring times will be recorded.
IGRT Assessment The patient will be set up on the breast board in treatment position. The 'ultra path' component of the Clarity system, which displays the path of the previous US acquired at CT simulation, will be used to guide the acquisition of US2. Although performed in the simulator room, the Clarity system will be used in 'treatment mode' thus simulating Clarity as it is used for IGRT. The study RT will first acquire the US2 scan. All steps following the acquisition of US2 will be performed off-line on the RM workstation without the need for further simulator or patient time.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Can 3D Ultrasound Be Used Reproducibly by Radiation Therapists in Partial Breast Image-Guided Radiation Therapy?|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
- Procedure: Image-Guided Radiation Therapy using 3D Ultrasound Guided-Therapy
Subjects will have 3 x 3DUS during radiation therapy
- Procedure: Ultrasound Guided Imaging
Subjects will undergo a CT scan and an US of your breast for the planning of radiation therapy after a breast conserving operation.
About 1 week after the start of radiation treatment subjects will have a second CT and US. During this visit subjects will have one CT and three US's. These US's will be performed by 3 different radiation therapists. Part of the current study is to compare the similarity of the 3 US pictures taken by different individuals.
- Procedure: 3 DUS
- Will the Clarity of breast IGRT product have the potential to improve localization through its ability to compare 3DUS at the time of planning to 3DUS at the time of treatment. [ Time Frame: Outcome will be measured three times during the 3DUS ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911456
|Canada, British Columbia|
|BC Cancer Agency Vancouver Island BCCA|
|Victoria, British Columbia, Canada, V8R 6V5|
|Principal Investigator:||Tanya Berrang||British Columbia Cancer Agency|