MRI-guided ultrasound treatment for skin cancer
MRI-Guided Focused Ultrasound Radiosensitization for Patients With Malignant Melanoma and Non Melanoma Skin Cancer
This study is testing a new treatment that uses ultrasound and microbubbles to see if it can make radiation therapy work better for people with skin cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05620290 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of MRI-guided focused ultrasound combined with microbubble therapy and radiotherapy for patients with malignant melanoma and non-melanoma skin cancer. The approach utilizes low-power ultrasound to stimulate microbubbles in the tumor before administering radiation, aiming to enhance the therapeutic effect. The primary goal is to assess the safety profile of this combined treatment, while the secondary goal focuses on evaluating the tumor response through radiological measurements.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with biopsy-confirmed malignant melanoma or non-melanoma skin cancer, including metastatic lesions.
Not a fit: Patients who are pregnant or lactating, or those with certain health conditions that prevent participation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve the efficacy of radiotherapy for patients with skin cancer.
How similar studies have performed: Other studies have shown promise with similar ultrasound and microbubble approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full 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
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Dr. Gregory Czarnota, MD, Ph.D. — Sunnybrook Health Sciences Centre
- Study coordinator: Dr. Gregory Czarnota, MD, Ph.D.
- Email: Gregory.Czarnota@sunnybrook.ca
- Phone: (416) 480-6128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.