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New treatment option for Melanoma
Official title MRI-Guided Focused Ultrasound Radiosensitization for Patients With Malignant Melanoma and Non Melanoma Skin Cancer
ClinicalTrials.gov ID: NCT05620290
What this study is testing
What is Definity?
Definity is an investigational medicine, being studied as a potential treatment for melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 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.
You likely can't join if
- Pregnant or lactating women may not participate due to the embryotoxic effects of protocol treatment. Women/ men of reproductive potential may not...
- 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...
See the full eligibility criteria
- Age ≥18 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
- 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...
- 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 people with a family or personal history of QT prolongation or taking concomitant medications known to cause QTc prolongation like cisapride, erythromycin, tricyclic...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.