HIFU Treatment of Cutaneous Neurofibromas in Neurofibromatosis Type 1: Safety and Efficacy

Inclusion Criteria

• •Males and females 18 years of age or older.
• •Patients with a clinical diagnosis of NF1 based on germline genetic testing or by meeting the internationally recognized criteria given by the Clinical Care Advisory Board of the National Neurofibromatosis Foundation (now the Children's Tumor Foundation)
• •Patients must be seeking active treatment for cNF.
• •Patients must have ≥ 8 paired cNF that are visible and measure a minimum of 2 mm in size. These must be in areas amenable to treatment and surveillance.
• •Patients with Fitzpatrick Type I to VI skin-type
• •Able and willing to comply with all visits, treatments, evaluations, schedules, and requirements.
• •Patients shall have received oral and written study information, accepted participation and signed the informed consent document.
• •Patients who are willing and mentally and physically capable to understand and follow the treatment and follow-up schedule including post-treatment care instructions.
• •Patients who are willing to have photographs and images taken of the treated lesions to be used anonymously or coded in evaluations and publications.