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RecruitingNCT05620290Updated Dec 15, 2023

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

A Phase 1 interventional study of Definity and Sonalleve Focused Ultrasound Device in Melanoma, sponsored by Sunnybrook Health Sciences Centre. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-15.

Sponsored by Sunnybrook Health Sciences Centre · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Jun 2022; still recruiting 4 years 3 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Melanoma

Keywords

  • Focused ultrasound
  • Melanoma
  • Microbubbles
03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's planned enrollment of 20 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Treatment Arm

    Malignant Melanoma patients undergoing MRI-guided ultrasound-stimulated microbubble treatment plus radiation therapy

    Drug: Definity · Device: Sonalleve Focused Ultrasound Device

Interventions

  • DrugDefinity

    Stimulation of Definity microbubbles using Sonalleve device within tumour vasculature

  • DeviceSonalleve Focused Ultrasound Device

    Sonalleve Focused Ultrasound Device

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 90 days

Secondary outcomes

  1. 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.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario M4N 3M5, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05620290
Lead sponsor
Sunnybrook Health Sciences Centre
Collaborators
Terry Fox Research Institute
Responsible party
Sponsor
First posted
Nov 17, 2022
Start date
Jun 15, 2022
Primary completion
Jul 11, 2025 (estimated)
Completion
Jul 11, 2028 (estimated)
Last update
Dec 15, 2023

Study contacts

Dr. Gregory Czarnota, MD, Ph.D.
Contact
Gregory.Czarnota@sunnybrook.ca
(416) 480-6128
Dr. Gregory Czarnota, MD, Ph.D.
principal investigator · Sunnybrook Health Sciences Centre

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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