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Completed

NCT Number: NCT00911456

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

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).

Completed

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

BC Cancer Agency Vancouver Island BCCA

Victoria, British Columbia, V8R 6V5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Image-Guided Radiation Therapy using 3D Ultrasound Guided-Therapy

Procedure

Subjects will have 3 x 3DUS during radiation therapy

Ultrasound Guided Imaging

Procedure

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.

3 DUS

Procedure

3 DUS

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Registry information

Official study title

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

Acronym: IGRT

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 2, 2009
Registry last updated
Feb 17, 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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