RecruitingPhase 1NCT05620290

MRI-Guided Focused Ultrasound Radiosensitization for Patients With Malignant Melanoma and Non Melanoma Skin Cancer


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

20 participants

Start Date

Jun 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this study is to examine the safety profile and therapeutic efficacy of MRI-guided focused ultrasound microbubble therapy and radiotherapy in humans.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using MRI-guided focused ultrasound — a non-invasive technology that uses sound waves to heat tissue — before radiation therapy can make skin cancer (melanoma and non-melanoma) more sensitive to radiation, potentially improving treatment outcomes. **You may be eligible if...** - You are 18 or older with biopsy-confirmed malignant melanoma or non-melanoma skin cancer (including metastatic lesions) - You are referred for radiation therapy and are also on immunotherapy - Your target tumor is visible on MRI and accessible for the focused ultrasound procedure - You weigh less than 140 kg and can hold still during treatment - Your kidney function meets required levels **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are unable to have a contrast-enhanced MRI scan - Your tumor has broken through the skin surface causing ulceration or bleeding - You have severe heart, brain, kidney, or blood problems - Your general health is too poor (ECOG 3 or worse) or you cannot hold still during treatment 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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NCT05620290


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