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Can 3D Ultrasound Be Used Reproducibly by Radiation Therapists in Partial Breast Image-Guided Radiation Therapy?

Phase 3
18 Years
80 Years
Not Enrolling
Radiation Therapy for Primary Breast Cancer

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Trial Information

Can 3D Ultrasound Be Used Reproducibly by Radiation Therapists in Partial Breast Image-Guided Radiation Therapy?

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

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.

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

Outcome will be measured three times during the 3DUS

Safety Issue:


Principal Investigator

Tanya Berrang

Investigator Role:

Principal Investigator

Investigator Affiliation:

British Columbia Cancer Agency


Canada: Ethics Review Committee

Study ID:




Start Date:

October 2009

Completion Date:

October 2011

Related Keywords:

  • Radiation Therapy for Primary Breast Cancer
  • Breast Neoplasms