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Automating Breast Radiation Therapy (RT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00923871
Recruitment Status : Active, not recruiting
First Posted : June 18, 2009
Last Update Posted : May 5, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
Breast radiation treatment is planned from a Computed Tomography (CT) scan. This study is designed to investigate a method to reduce the time between the planning of radiation treatment and its actual start by automating the intensity-modulated radiation therapy (IMRT) planning process. The investigators plan to examine data from another scan called Cone Beam Computed Tomography (CBCT). A CBCT scan provides similar information to a conventional CT scan, however the images for CBCT are acquired at the treatment unit (linear accelerator used for treatment). Using these x-ray pictures of patients, the study team consisting of a radiation oncologist, a medical physicist and a radiation therapist will create a custom treatment plan unique to each patient. By doing this, the investigators hope to reduce the amount of time spent waiting for treatment and the number of hospital visits for patients in the future.

Condition or disease Intervention/treatment
Breast Cancer Procedure: Cone Beam CT

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Automating the Breast Radiation Therapy Process to Improve Efficiency
Study Start Date : June 2009
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cone Beam CT Procedure: Cone Beam CT
Patients will also have a CBCT scan when they are having their first IMRT treatment.

Outcome Measures

Primary Outcome Measures :
  1. To generate on-line IMRT treatment plans using automated tools based on CBCT images acquired at the treatment unit. [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients with breast cancer who will receive standard two-field tangential whole breast radiation therapy with dose prescription of 4240 cGy in 16 fractions, 5000 cGy in 25 fractions or 4000 cGy in 16 fractions.
  • Patients with any stage of breast cancer.
  • Patients with prior treatment such as surgery or chemotherapy for any type of cancer.
  • Able to provide a written informed consent.
  • 18 years of age or older.

Exclusion Criteria:

  • < 18 years of age.
  • Unable to provide informed consent.
  • Males.
  • Patients who received partial breast radiation and not the standard dose.
  • Patients who will not receive 4240 cGy in 16 fractions, 5000 cGy in 25 fractions, or 4000 cGy in 16 fractions.
Contacts and Locations

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): NCT00923871

Canada, Ontario
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: Anne Koch, MD University Health Network, Princess Margaret Hospital
More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00923871     History of Changes
Other Study ID Numbers: UHN REB 09-0197-CE
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017

Keywords provided by University Health Network, Toronto:
Breast Cancer