MRI-Guided Focused Ultrasound Radiosensitization for Patients With Malignant Melanoma and Non Melanoma Skin Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Definity, Sonalleve Focused Ultrasound Device.
- Who it may be relevant to
- Registry conditions: Melanoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Interventions
- Drug Definity
Stimulation of Definity microbubbles using Sonalleve device within tumour vasculature - Device Sonalleve Focused Ultrasound Device
Sonalleve Focused Ultrasound Device
Primary outcome measures
- Incidence of toxicity and adverse events, scored on the National Cancer Institute Common Toxicity Criteria (NCI CTCAE 4.03) [Time frame: 90 days]
Secondary outcome measures (1)
- Radiological response [Time frame: 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Sunnybrook Health Sciences Centre — Toronto
Identifiers
NCT: NCT05620290 · 4877