Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05620290

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

Led by Sunnybrook Health Sciences Centre · Updated on 2023-12-15

20

Participants Needed

1

Research Sites

316 weeks

Total Duration

On this page

Sponsors

S

Sunnybrook Health Sciences Centre

Lead Sponsor

T

Terry Fox Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6518 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
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women.
  • Women or men of reproductive potential not agreeing to use effective contraception.
  • Unable to have contrast-enhanced MRI scan.
  • Target lesion involves skin surface causing ulceration, bleeding, or discharge.
  • Severe cardiovascular, neurological, renal or hematological chronic disease.
  • ECOG Performance Status 653; 3 or unable to tolerate required stationary position during treatment.
  • Cardiac disease or unstable hemodynamics including recent myocardial infarction, unstable angina, congestive heart failure, ejection fraction < 50%, cardiac shunts, arrhythmia, or pacemaker.
  • Contraindication to perflutren including history of QT prolongation or taking medications known to cause QTc prolongation.
  • Severe hypertension (diastolic BP > 100 mmHg).
  • History of bleeding disorder or coagulopathy.
  • Severely impaired renal function with estimated glomerular filtration rate < 30 ml/min/1.73 m2 and/or on dialysis.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

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Research Team

D

Dr. Gregory Czarnota, MD, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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