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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of toxicity and adverse events, scored on the National Cancer Institute Common Toxicity Criteria (NCI CTCAE 4.03)
Secondary outcome measures
Radiological response
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
~520
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
657 Previous Clinical Trials
1,551,162 Total Patients Enrolled
1 Trials studying Melanoma
24 Patients Enrolled for Melanoma
Terry Fox Research InstituteOTHER
8 Previous Clinical Trials
1,318 Total Patients Enrolled
1 Trials studying Melanoma
500 Patients Enrolled for Melanoma
Dr. Gregory Czarnota, MD, Ph.D.Principal InvestigatorSunnybrook Health Sciences Centre
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Treatment Arm been approved by the FDA?
"Treatment Arm's safety rating is 1 due to its Phase 1 status, meaning there are limited data points proving both efficacy and safety."
Answered by AI
To what extent is the patient population participating in this clinical trial expanding?
"Affirmative. The clinicaltrials.gov website attests to the active recruitment of patients for this experiment, which was first posted on June 15th 2022 and recently modified in November 16th 2022. Currently, 20 individuals from a single medical facility are sought after for participation."
Answered by AI
Are there vacancies for volunteers in this study?
"Clinicialtrials.gov confirms that this medical research project, which was initially posted on June 15th 2022 is actively enrolling candidates. The page has been updated as recently as November 16th of the same year."
Answered by AI
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