Automated Breast Radiation Therapy Using an MR-Guided Process

NCT01999062 | Completed DMC

• 1 other identifier: 12-5181
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast RT; Breast radiation therapy

Outcome Measures

Primary Outcomes (2)

• Time between planning of Radiation treatment and the start of radiotherapy

  3 years

• The effect of breathing on the position of the heart and lung in treatment plans

  3 years

Study Arms (1)

IMRT + CT + MR scan

EXPERIMENTAL

Other: IMRT + CT + MR scan

Interventions

IMRT + CT + MR scan OTHER

IMRT + CT + MR scan

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Robert Dinniwell, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

• Tom Purdie, Physicist

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: December 3, 2013
• Study Start: March 1, 2013
• Primary Completion: January 27, 2026
• Study Completion: January 27, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

CA (1)