Automating Breast Radiation Therapy (RT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Health Network, Toronto
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00923871
First received: June 16, 2009
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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 Intervention
Breast Cancer
Procedure: Cone Beam CT

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Automating the Breast Radiation Therapy Process to Improve Efficiency

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • To generate on-line IMRT treatment plans using automated tools based on CBCT images acquired at the treatment unit. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: June 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cone Beam CT Procedure: Cone Beam CT
Patients will also have a CBCT scan when they are having their first IMRT treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923871

Contacts
Contact: Robert Dinniwell, MD 416 946 4501 ext 4662 robert.dinniwell@rmp.uhn.on.ca
Contact: Tom Purdie, PhD 416 946 4501 ext 5074 Tom.purdie@rmp.uhn.on.ca

Locations
Canada, Ontario
University Health Network, Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Robert Dinniwell, MD    416 946 4501 ext 4662    Robert.Dinniwell@rmp.uhn.on.ca   
Contact: Tom Purdie, PhD    416 946 4501 ext 5074    Tom.purdie@rmp.uhn.on.ca   
Principal Investigator: Robert Dinniwell, MD         
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Robert Dinniwell, MD University Health Network, Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00923871     History of Changes
Other Study ID Numbers: UHN REB 09-0197-CE
Study First Received: June 16, 2009
Last Updated: June 24, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
CBCT
Breast Cancer

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

ClinicalTrials.gov processed this record on July 28, 2014