Recruiting
Phase 1

MRI-Guided Focused Ultrasound

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05620290

Conditions

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Definity

Sonalleve Focused Ultrasound Device

Study Details

Brief 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.

Conditions

Melanoma

Study ID

NCT05620290

Start date

Jun 15, 2022

Status verified date

Dec, 2023

Completion date

Jul 11, 2028

Anticipated

Primary completion date

Jul 11, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Arm

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

Interventions

Definity

Stimulation of Definity microbubbles using Sonalleve device within tumour vasculature

Sonalleve Focused Ultrasound Device

Sonalleve Focused Ultrasound Device

Primary outcome measure

  • Incidence of toxicity and adverse events, scored on the National Cancer Institute Common Toxicity Criteria (NCI CTCAE 4.03) [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Dr. Gregory Czarnota, MD, Ph.D.

(416) 480-6128Gregory.Czarnota@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Gregory J Czarnota, MD, PhD

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

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Dec 15, 2023

Last verified

Dec, 2023

Keywords

  • Focused ultrasound
  • Melanoma
  • Microbubbles

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2023-12-15.