Ultrasound With Microbubbles Plus Radiotherapy for Skin Cancer
Tests focused ultrasound with microbubbles and radiation in adults with melanoma.
Plain-language title generated from the registry record
Registry title: MRI-Guided Focused Ultrasound Radiosensitization for Patients With Malignant Melanoma and Non Melanoma Skin Cancer
Key facts
- Where
- Toronto, CanadaSee the site
- Phase
- Phase 1
Where in Canada
- Sunnybrook Health Sciences CentreToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sunnybrook Health Sciences Centre
- Trial code
- NCT05620290
- Record updated
- 15 December 2023
- Original description
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.Read full original descriptionShow less
MRI-Guided Focused Ultrasound Radiosensitization for Patients With Malignant Melanoma and Non Melanoma Skin Cancer
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.
Inclusion: 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: Target lesion involves the skin surface causing ulceration, bleeding or discharge; Severe cardiovascular, neurological, renal or hematological chronic disease; Severe hypertension (diastolic BP > 100 mmHg); History of bleeding disorder, coagulopathy; 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; 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; ECOG (Eastern Cooperative Oncology Group) Performance Status ≥ 3. Unable to tolerate required stationary position during treatment; Severely impaired renal function with estimated glomerular filtration rate < 30ml/min/1.73m2 and/or on dialysis.