Automated Breast Radiation Therapy Using an MR-Guided Process

Breast Cancer Clinical Trial

Official title:

Automated Breast Radiation Therapy Using an MR-Guided Process

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01999062
• Other study ID #: UHN REB 12-5181-CE
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2013
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the proposed research study, we are investigating the feasibility of integrating automated planning tools to MR images acquired using a novel MR-guided linac, for on-line adaptive radiation treatment. However, these on-line automation tools require further technical refinement and clinical validation. The goal of this research proposal is to develop an on-line MR-guided radiation therapy process for adapting breast IMRT treatment. Such an approach will provide early stage breast cancer patients timely access to high-quality adaptive treatments without exposure to additional ionizing radiation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients 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.

• Female 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.

Exclusion Criteria:

• Patients who will not receive 4240 cGy in 16 fractions, 5000 cGy in 25 fractions, or 4000 cGy in 16 fractions

• Males.

• Patients who received partial breast radiation and not the standard dose.

• Patients who are unable to provide informed consent.

• < 18 years of age.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• IMRT + CT + MR scan

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time between planning of Radiation treatment and the start of radiotherapy		3 years
Primary	The effect of breathing on the position of the heart and lung in treatment plans		3 years