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Clinical Trial 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.


Clinical Trial Description

The approach uses relatively low-power ultrasound, operating with lower power levels than high intensity focused ultrasound and ultrasound-based hyperthermia techniques, delivered on the Sonalleve platform. The tumour will be sonicated before the radiation to enhance the effect of therapy. The technique is spatially targeted and stimulates microbubbles using low-power ultrasonic fields in the tumour location only. the primary aim of this research is to evaluate the safety profile of MRI-guided ultrasound stimulated microbubble treatment and radiation in patients with malignant melanoma. The secondary aim is to evaluate tumour (primary and/or metastasis) response to MRI-guided ultrasound stimulated microbubble treatment and radiation, as measured radiologically within the treated regions. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05620290
Study type Interventional
Source Sunnybrook Health Sciences Centre
Contact Dr. Gregory Czarnota, MD, Ph.D.
Phone (416) 480-6128
Email Gregory.Czarnota@sunnybrook.ca
Status Recruiting
Phase Phase 1
Start date June 15, 2022
Completion date July 11, 2028

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