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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
Information provided by:
British Columbia Cancer Agency

Brief Summary:
To determine if the Clarity 3DUS (3D Ultrasound) system can be used by multiple individuals to acquire 3DUS images and produce consistent TB (Tumor Bed) shifts for breast IGRT (Image-Guided Radiation Therapy).

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

Detailed Description:

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)
Primary Purpose: Treatment
Official Title: Can 3D Ultrasound Be Used Reproducibly by Radiation Therapists in Partial Breast Image-Guided Radiation Therapy?
Study Start Date : October 2009
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Intervention Details:
    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
    3 DUS

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects will be 27 consenting women undergoing CT simulation for adjuvant breast radiotherapy at VIC ≤16 weeks after BCS.
  • Women must have primary tumors <3cm, pathologically N0 disease, and negative surgical margins.
  • Seroma clarity score <2

Exclusion Criteria:

  • Patients will be excluded if they have had mastectomy or receive adjuvant chemotherapy that results in the CT simulation session occurring >16 weeks after the BCS date.

Information from the National Library of Medicine

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
Sponsors and Collaborators
British Columbia Cancer Agency
Principal Investigator: Tanya Berrang British Columbia Cancer Agency

Responsible Party: Tanya Berrang, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT00911456     History of Changes
Other Study ID Numbers: 0001
First Posted: June 2, 2009    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: October 2009