RecruitingPhase 1NCT06633601

MRI-Guided Ultrasound Stimulated Microbubbles Radiation Treatment for Patients with Chest-Wall and Locally Advanced Breast Cancer

A Prospective, Single-Centre, Single-Arm, Non-Randomized, Phase-I, MRI-Guided Ultrasound Stimulated Microbubbles Radiation Treatment for Patients with Chest-Wall and Locally Advanced Breast Cancer - a Pilot Study


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

30 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining radiation therapy with ultrasound-activated microbubbles (tiny gas-filled bubbles) can improve treatment for chest wall and advanced breast cancer. The microbubbles are injected into the bloodstream and guided by MRI, then activated by focused ultrasound near the tumor to potentially help radiation work better and deliver more treatment to the tumor area. **You may be eligible if...** - You are 18 or older with confirmed breast cancer (any type), at early to advanced stages (Stage IIA–IV) - You are being referred for standard radiation therapy - Your kidneys are functioning adequately - Your weight is under 140 kg - The tumor area is accessible for the ultrasound procedure - You are able to remain still during treatment **You may NOT be eligible if...** - You are pregnant or breastfeeding - You cannot have an MRI with contrast (e.g., you have a pacemaker or metal implants) - You received certain chemotherapy (anthracycline or taxane) within the last 5 days - You have breast implants or metallic implants near the treatment area - You have severe heart disease, a bleeding disorder, or a heart shunt/pacemaker - You are allergic to Definity microbubbles or to perflutren - You have severe kidney disease 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

DEVICEMR-Guided Focused Ultrasound Technology

MRI Guidance for use with High-intensity-focused ultrasound (HIFUS)

DRUGDefinity Suspension for Injection

Microbubble contrast agents for ultrasound


Locations(1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT06633601


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