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

NCT00911456 | Completed Phase 3 DMC

• 1 other identifier: 0001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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).

Conditions

Radiation Therapy for Primary Breast Cancer

Outcome Measures

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.

  Outcome will be measured three times during the 3DUS

Interventions

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer Agency Vancouver Island BCCA

Victoria, British Columbia, V8R 6V5, Canada

Location

Study Officials

• Tanya Berrang

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 29, 2009
• First Posted: June 2, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 17, 2012

Record last verified: 2009-10

Locations

CA (1)