Automated Breast Radiation Therapy Using an MR-Guided Process

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01999062
• Collaborator: Princess Margaret Hospital, Canada (Other)
• Enrollment: 160
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 118
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: IMRT + CT + MR scan	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: Diagnostic
• Official Title: Automated Breast Radiation Therapy Using an MR-Guided Process
• Actual Study Start Date: Mar 1, 2013
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IMRT + CT + MR scan	Other: IMRT + CT + MR scan

Outcome Measures

Primary Outcome Measures

1. Time between planning of Radiation treatment and the start of radiotherapy [3 years]

2. The effect of breathing on the position of the heart and lung in treatment plans [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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Robert Dinniwell, M.D., Princess Margaret Cancer Centre
• Principal Investigator: Tom Purdie, Physicist, Princess Margaret Cancer Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT01999062
• Other Study ID Numbers: UHN REB 12-5181-CE
• First Posted: Dec 3, 2013
• Last Update Posted: Oct 7, 2022
• Last Verified: Oct 1, 2022

• Keywords provided by University Health Network, Toronto: Breast RT; Breast radiation therapy

Study Results

No Results Posted as of Oct 7, 2022