NCT05620290 MRI-Guided Focused Ultrasound Radiosensitization for Patients With Malignant Melanoma and Non Melanoma Skin Cancer
| NCT ID | NCT05620290 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-06-15 |
| Primary Completion | 2025-07-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2022-06-15 with a primary completion date of 2025-07-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Dr. Gregory Czarnota, MD, Ph.D.
PRINCIPAL INVESTIGATOR
Sunnybrook Health Sciences Centre
Frequently Asked Questions
Who can join the NCT05620290 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05620290 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05620290 currently recruiting?
Yes, NCT05620290 is actively recruiting participants. Contact the research team at Gregory.Czarnota@sunnybrook.ca for enrollment information.
Where is the NCT05620290 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05620290 clinical trial?
NCT05620290 is sponsored by Sunnybrook Health Sciences Centre. The principal investigator is Dr. Gregory Czarnota, MD, Ph.D. at Sunnybrook Health Sciences Centre. The trial plans to enroll 20 participants.
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