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Device
Focused Ultrasound Radiosensitization for Melanoma
Phase 1
Recruiting
Led By Dr. Gregory Czarnota, MD, Ph.D.
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will study a new therapy combining ultrasound and radiation to safely treat diseases in people.
Who is the study for?
This trial is for adults over 18 with any stage of malignant melanoma who are referred for various types of radiotherapy and may be on immunotherapy. They must weigh less than 140kg, have a target lesion visible by MRI that's accessible for treatment, normal kidney function or mild impairment, and not be pregnant or breastfeeding. Participants need to use effective contraception if they can reproduce.
What is being tested?
The study tests the combination of an MRI-guided focused ultrasound device called Sonalleve and microbubble therapy using Definity with standard radiotherapy to see if it's safe and improves treatment outcomes in melanoma patients.
What are the potential side effects?
Potential side effects might include discomfort at the treatment site, skin reactions from the ultrasound procedure, allergic reactions to Definity microbubbles used during treatment, as well as typical side effects from radiotherapy like fatigue and skin irritation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of toxicity and adverse events, scored on the National Cancer Institute Common Toxicity Criteria (NCI CTCAE 4.03)
Secondary study objectives
Radiological response
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment2 Interventions
Malignant Melanoma patients undergoing MRI-guided ultrasound-stimulated microbubble treatment plus radiation therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Definity
2007
Completed Phase 4
~540
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,565,469 Total Patients Enrolled
1 Trials studying Melanoma
24 Patients Enrolled for Melanoma
Terry Fox Research InstituteOTHER
10 Previous Clinical Trials
1,548 Total Patients Enrolled
1 Trials studying Melanoma
500 Patients Enrolled for Melanoma
Dr. Gregory Czarnota, MD, Ph.D.Principal InvestigatorSunnybrook Health Sciences Centre
1 Previous Clinical Trials
200 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am referred for a specific type of radiotherapy.My cancer can be targeted with a specific type of focused ultrasound.I have a confirmed diagnosis of skin cancer, including melanoma or non-melanoma types.I need help with my daily activities due to my health condition.My blood pressure is very high (over 100 mmHg diastolic).I am currently receiving immunotherapy.I am using birth control if I can have children.My kidney function is severely impaired or I am on dialysis.I cannot stay still for long periods during treatment.I haven't had heart disease or unstable blood pressure in the last 6 months.My cancer causes skin ulcers, bleeding, or discharge.I do not have severe heart, brain, kidney, or blood diseases.My skin cancer is between stage I and IV, according to AJCC guidelines.My kidney function, measured by creatinine levels, is normal or nearly normal.I cannot undergo MRI scans with contrast due to health reasons.I am 18 years old or older.I can communicate how I feel during MRg-FU treatment.I have a history of bleeding disorders.I cannot take perflutren due to health reasons.I understand the study and can give my consent.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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