Automating Breast Radiation Therapy (RT)

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00923871
• Collaborator: Princess Margaret Hospital, Canada (Other)
• Enrollment: 160
• Location: 1
• Arm: 1
• Duration (Months): 154
• Patients Per Site Per Month: 1

Study Details

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	Phase
Breast Cancer	Procedure: Cone Beam CT	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: N/A
• 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: Jun 1, 2009
• Actual Primary Completion Date: Jan 5, 2015
• Anticipated Study Completion Date: Apr 1, 2022

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. [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	University Health Network, Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

• University Health Network, Toronto
• Princess Margaret Hospital, Canada

Investigators

• Principal Investigator: Anne Koch, MD, University Health Network, Princess Margaret Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT00923871
• Other Study ID Numbers: UHN REB 09-0197-CE
• First Posted: Jun 18, 2009
• Last Update Posted: Oct 5, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by University Health Network, Toronto: CBCT; Breast Cancer
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Oct 5, 2021