RecruitingPhase 2NCT06185972

Novel Magnetic Resonance Imaging-Guided Ultrasound-Stimulated Microbubble Radiation Treatment for Patients With Chest-Wall and Breast Cancer

Novel Magnetic Resonance Imaging-Guided Ultrasound-Stimulated Microbubble Radiation Treatment for Patients With Chest-Wall and Locally Advanced Breast Cancer-Phase II


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

200 participants

Start Date

Jul 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this study is to demonstrate the efficacy and response 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new approach that combines MRI-guided focused ultrasound with tiny gas-filled bubbles (microbubbles) to make breast or chest-wall cancer tumors more sensitive to radiation therapy. The goal is to improve treatment effectiveness without increasing side effects. **You may be eligible if...** - You are 18 or older - You have biopsy-confirmed invasive breast cancer (any type) - You have early-stage, locally advanced, or metastatic breast cancer (Stage IIA to Stage IV) - A multidisciplinary medical team has recommended you as a candidate for this combined treatment approach **You may NOT be eligible if...** - You have a pacemaker or other implanted device incompatible with MRI - You have a known allergy to ultrasound contrast agents (microbubbles) - You have serious heart or lung problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDefinity

Stimulation of Definity microbubbles using Sonalleve device within tumour vasculature

DEVICESonalleve Focused Ultrasound Device

Sonalleve Focused Ultrasound Device


Locations(1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT06185972


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