All > Malignant Melanoma

Treatment Arm for Melanoma

Sunnybrook Health Sciences Centre, Toronto, Canada
MelanomaDefinity - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study a new therapy combining ultrasound and radiation to safely treat diseases in people.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 2 years

2 years
Radiological response
90 days
Incidence of toxicity and adverse events, scored on the National Cancer Institute Common Toxicity Criteria (NCI CTCAE 4.03)

Trial Safety

Phase-Based Safety

1 of 3

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1
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1
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Treatment Arm
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Treatment Arm · No Placebo Group · Phase 1

Treatment ArmExperimental Group · 2 Interventions: Definity, Sonalleve Focused Ultrasound Device · Intervention Types: Drug, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Definity
2007
Completed Phase 4
~510

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
615 Previous Clinical Trials
1,470,546 Total Patients Enrolled
1 Trials studying Melanoma
24 Patients Enrolled for Melanoma
Terry Fox Research InstituteOTHER
7 Previous Clinical Trials
1,118 Total Patients Enrolled
1 Trials studying Melanoma
500 Patients Enrolled for Melanoma
Dr. Gregory Czarnota, MD, Ph.D.Principal InvestigatorSunnybrook Health Sciences Centre

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The lesion being studied can be reached with magnetic resonance-guided focused ultrasound procedure.
You are able to tell the doctors if you feel any sensations during MRg-FU treatment.
You are currently receiving radiation therapy as a treatment option.
You are currently receiving immunotherapy.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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