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

NCT ID: NCT05620290

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-15

Study Completion Date

2028-07-11

Brief Summary

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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

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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.

Conditions

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Melanoma

Keywords

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Focused ultrasound Melanoma Microbubbles

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Arm

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

Group Type EXPERIMENTAL

Definity

Intervention Type DRUG

Stimulation of Definity microbubbles using Sonalleve device within tumour vasculature

Sonalleve Focused Ultrasound Device

Intervention Type DEVICE

Sonalleve Focused Ultrasound Device

Interventions

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Definity

Stimulation of Definity microbubbles using Sonalleve device within tumour vasculature

Intervention Type DRUG

Sonalleve Focused Ultrasound Device

Sonalleve Focused Ultrasound Device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Terry Fox Research Institute

OTHER

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Gregory Czarnota, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Dr. Gregory Czarnota, MD, Ph.D.

Role: CONTACT

Phone: (416) 480-6128

Email: [email protected]

Facility Contacts

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Gregory J Czarnota, MD, PhD

Role: primary

Other Identifiers

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4877

Identifier Type: -

Identifier Source: org_study_id