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MRI-Guided Focused Ultrasound Radiosensitization for Patients With Malignant Melanoma

Primary Purpose

Melanoma

Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Definity
Sonalleve Focused Ultrasound Device
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Focused ultrasound, Melanoma, Microbubbles

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 years All biopsy-confirmed malignant melanoma of the skin, including metastatic lesions. Stage I-IV malignant melanoma, 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 normal 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

Sites / Locations

  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 17, 2022
Last Updated
November 16, 2022
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Terry Fox Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05620290
Brief Title
MRI-Guided Focused Ultrasound Radiosensitization for Patients With Malignant Melanoma
Official Title
MRI-Guided Focused Ultrasound Radiosensitization for Patients With Malignant Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
June 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Terry Fox Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Focused ultrasound, Melanoma, Microbubbles

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Malignant Melanoma patients undergoing MRI-guided ultrasound-stimulated microbubble treatment plus radiation therapy
Intervention Type
Drug
Intervention Name(s)
Definity
Intervention Description
Stimulation of Definity microbubbles using Sonalleve device within tumour vasculature
Intervention Type
Device
Intervention Name(s)
Sonalleve Focused Ultrasound Device
Intervention Description
Sonalleve Focused Ultrasound Device
Primary Outcome Measure Information:
Title
Incidence of toxicity and adverse events, scored on the National Cancer Institute Common Toxicity Criteria (NCI CTCAE 4.03)
Description
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 Outcome Measure Information:
Title
Radiological response
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years All biopsy-confirmed malignant melanoma of the skin, including metastatic lesions. Stage I-IV malignant melanoma, 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 normal 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Gregory Czarnota, MD, Ph.D.
Phone
(416) 480-6128
Email
Gregory.Czarnota@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Gregory Czarnota, MD, Ph.D.
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory J Czarnota, MD, PhD
Phone
(416) 480-6128
Email
gregory.czarnota@sunnybrook.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

MRI-Guided Focused Ultrasound Radiosensitization for Patients With Malignant Melanoma

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