CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 20 target
Drug / intervention
Definity +1 moredrug
Likely dose
Not stated in record
Key inclusion· 10
  • ✓Age 18 years or older
  • ✓Biopsy-confirmed malignant melanoma of skin and non-melanoma skin cancer, including metastatic lesions
  • ✓Stage I-IV disease per AJCC 8th Edition guidelines
  • ✓Referred for palliative, standard, neoadjuvant, or SBRT radiotherapy
Key exclusion· 10
  • ✕Pregnant or lactating women; women/men of reproductive potential without agreement to use effective contraception
  • ✕Unable to have contrast-enhanced MRI scan
  • ✕Target lesion involves skin surface with ulceration, bleeding, or discharge
  • ✕Severe cardiovascular, neurological, renal, or hematological chronic disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05620290
NCT05620290Phase 1RecruitingUpdate OverdueUpdated 30mo ago · Completion was 11mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

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

Sunnybrook Health Sciences Centre·interventional·Posted Nov 17, 2022·Updated Dec 15, 2023

In Brief

A Phase 1 clinical trial evaluating Definity and Sonalleve Focused Ultrasound Device for Melanoma. Currently recruiting, targeting 20 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesCanada
CollaboratorsTerry Fox Research Institute

Timeline

Phase 1Recruiting
202320242025202620272028
First PostedNov 17, 2022
Enrollment StartJun 15, 2022
Primary CompletionJul 11, 2025
Study CompletionJul 11, 2028
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 3.6 years ago

Interventions

Definitydrug

Stimulation of Definity microbubbles using Sonalleve device within tumour vasculature

Sonalleve Focused Ultrasound Devicedevice

Sonalleve Focused Ultrasound Device