The objective of this study is to demonstrate the feasibility of novel Magnetic Resonance Imaging (MRI)-guided ultrasound stimulated microbubble treatment to enhance radiation effects in humans receiving external beam radiotherapy delivered using a LINAC (linear accelerator) radiation therapy device.
This is a prospective, single-centre, single-arm, non-randomized phase one (Phase I) clinical trial. In this study, locally advanced breast cancer (LABC) and breast/chest wall tumours not managed by surgery, patients will receive MRI-guided ultrasound-stimulated microbubble-treatment using an Arrayus MRI-FUS System combined with radiotherapy on a LINAC. Patients will lie on the MRI table with an in-built focused ultrasound platform where the tumour is kept in close contact with the transducer of the ultrasound. After exposure to the tumour with focused ultrasound, the patient will receive a standard of care LINAC-based radiation therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
MRI Guidance for use with High-intensity-focused ultrasound (HIFUS)
Microbubble contrast agents for ultrasound
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
RECRUITINGSafety profile of MRI- guided ultrasound stimulated microbubble treatment and radiation in patients with inoperable breast/chest wall tumours or LABC.
The primary aim of this research is to evaluate the safety profile of MRI- guided ultrasound stimulated microbubble treatment and radiation in patients with inoperable breast/chest wall tumours or LABC.Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 2 years
Tumour size response to MRg-FUS + MB and radiation, as measured radiologically or clinically within the treated therapeutic regions.
The secondary aim of this research is to evaluate tumour response to MRg-FUS + MB and radiation, as measured radiologically or clinically within the treated therapeutic regions. Outcomes will be measured using RECIST criteria.
Time frame: 2 years
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