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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age ≥18 years.

- All biopsy-confirmed malignant melanoma of the skin and non melanoma skin cancer, including metastatic lesions.

- Stage I-IV malignant melanoma and non melanoma skin cancer, per AJCC guidelines (8th Edition).

- Patient referred for palliative radiotherapy/ standard radiotherapy/ neoadjuvant radiotherapy/ SBRT/ hypofractionation.

- Patient on immunotherapy.

- Able to understand and give informed consent.

Weight <140kg.

- Target lesion visible by non-contrast MRI.

- Target lesion accessible for MRg-FU procedure.

- Able to communicate sensation during MRg-FU treatment.

- Creatinine within normal institutional limits or creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above the institutional upper limit of norma.

Exclusion Criteria:

- Pregnant or lactating women may not participate due to the embryotoxic effects of protocol treatment.

Women/ men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.

- Unable to have contrast-enhanced MRI scan - the standard of care criteria.

- Target lesion involves the skin surface causing ulceration, bleeding or discharge.

- Severe cardiovascular, neurological, renal or hematological chronic disease.

- ECOG (Eastern Cooperative Oncology Group) Performance Status ≥ 3.

Unable to tolerate required stationary position during treatment.

- Cardiac disease or unstable hemodynamics, including myocardial infarction within six months, unstable angina, congestive heart failure, ejection fraction < 50%, cardiac shunts, cardiac arrhythmia and cardiac pacemaker.

- Contraindication to perflutren including subjects with a family or personal history of QT prolongation or taking concomitant medications known to cause QTc prolongation like cisapride, erythromycin, tricyclic antidepressants, Class IA and III antiarrhythmic agents and some antipsychotics like haloperidol, droperidol, quetiapine, thioridazine, ziprasidone.

- Severe hypertension (diastolic BP > 100 mmHg) - History of bleeding disorder, coagulopathy.

- Severely impaired renal function with estimated glomerular filtration rate < 30ml/min/1.73m2 and/or on dialysis

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05620290
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sunnybrook Health Sciences Centre
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Dr. Gregory Czarnota, MD, Ph.D.
Principal Investigator Affiliation	Sunnybrook Health Sciences Centre
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Treatment Arm

Malignant Melanoma patients undergoing MRI-guided ultrasound-stimulated microbubble treatment plus radiation therapy

Interventions

Drug: - Definity

Stimulation of Definity microbubbles using Sonalleve device within tumour vasculature

Device: - Sonalleve Focused Ultrasound Device

Sonalleve Focused Ultrasound Device

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.