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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05620290
Other study ID # 4877
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date June 15, 2022
Est. completion date July 11, 2028

Study information

Verified date December 2023
Source Sunnybrook Health Sciences Centre
Contact Dr. Gregory Czarnota, MD, Ph.D.
Phone (416) 480-6128
Email Gregory.Czarnota@sunnybrook.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date July 11, 2028
Est. primary completion date July 11, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Definity
Stimulation of Definity microbubbles using Sonalleve device within tumour vasculature
Device:
Sonalleve Focused Ultrasound Device
Sonalleve Focused Ultrasound Device

Locations

Country Name City State
Canada Sunnybrook Health Sciences Centre Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre Terry Fox Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of toxicity and adverse events, scored on the National Cancer Institute Common Toxicity Criteria (NCI CTCAE 4.03) The patient will be assessed by a physician investigator and clinical research assistant (CRA) on the MRI-guided focused ultrasound + microbubble (MRgFUS + MB) treatment date and within follow up period of 90 days after treatment. 90 days
Secondary Radiological response The secondary aim is to evaluate tumour (primary and/or metastasis) response to MRgFUS + MB and radiation, which will be evaluated by tumour volume change. 2 years
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