MRI-Guided Focused Ultrasound Radiosensitization for Patients With Malignant Melanoma and Non Melanoma Skin Cancer

Trial Title: MRI-Guided Focused Ultrasound Radiosensitization for Patients With Malignant Melanoma and Non Melanoma Skin Cancer

NCT ID: NCT05620290

Condition: Melanoma

Conditions: Official terms:
Melanoma
Skin Neoplasms

Conditions: Keywords:
Focused ultrasound
Melanoma
Microbubbles

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Definity
Description: Stimulation of Definity microbubbles using Sonalleve device within tumour vasculature
Arm group label: Treatment Arm

Intervention type: Device
Intervention name: Sonalleve Focused Ultrasound Device
Description: Sonalleve Focused Ultrasound Device
Arm group label: Treatment Arm

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.

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Sunnybrook Health Sciences Centre

Address:
City: Toronto
Zip: M4N 3M5
Country: Canada

Status: Recruiting

Contact:
Last name: Gregory J Czarnota, MD, PhD

Phone: (416) 480-6128
Email: gregory.czarnota@sunnybrook.ca

Start date: June 15, 2022

Completion date: July 11, 2028

Lead sponsor:
Agency: Sunnybrook Health Sciences Centre
Agency class: Other

Collaborator:
Agency: Terry Fox Research Institute
Agency class: Other

Source: Sunnybrook Health Sciences Centre

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05620290