MRI-Guided Focused Ultrasound Radiosensitization for Patients With Malignant Melanoma and Non Melanoma Skin Cancer
Recruiting · NCT05620290 · Interventional (participants receive a specific treatment) · Lead sponsor: Sunnybrook Health Sciences Centre
View the official record on ClinicalTrials.gov →Interventions studied
DefinitySonalleve Focused Ultrasound Device
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Sunnybrook Health Sciences Centre - Toronto, Ontario, Canada