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

This study has been completed.
Sponsor:
Information provided by:
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00911456
First received: May 29, 2009
Last updated: February 15, 2012
Last verified: October 2009
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Can 3D Ultrasound Be Used Reproducibly by Radiation Therapists in Partial Breast Image-Guided Radiation Therapy?

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: October 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00911456

Locations
Canada, British Columbia
BC Cancer Agency Vancouver Island BCCA
Victoria, British Columbia, Canada, V8R 6V5
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Principal Investigator: Tanya Berrang British Columbia Cancer Agency
  More Information

No publications provided

Responsible Party: Tanya Berrang, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT00911456     History of Changes
Other Study ID Numbers: 0001
Study First Received: May 29, 2009
Last Updated: February 15, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 31, 2014