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Clinical Trial Summary

The overall objective is to demonstrate safety and efficacy of HIFU treatment of cutaneous neurofibromas located close to the surface of the skin in patients with the genetic disease Neurofibromatosis Type 1. The study will use a new investigational equipment that has been specially developed for dermatological therapy. The study includes 20 patients in total distributed between the two centers, each having a minimum of 8 cutaneous neurofibromas eligible for treatment. All participants are adults (over 18 years) of both sexes. The new treatment method is based on focusing intensive ultrasound just below the skin surface. This creates a very fast localized heating in small and very well-defined volumes containing neurofibroma tissue. This heating destroys or weakens the tissue, and the body's natural processes will subsequently transport affected cells away through the lymphatic and vascular systems. During the healing-process, the rejected tissue is replaced by new skin cells that are not expected to be fibrous. The treatment is intended to be carried out without breaking the skin surface, and open wounds are therefore avoided. This is an essential advantage of the method compared to all existing therapies, which are based on physical removal of tumors through an open skin surface (e.g. surgery or laser therapy). Complications with risk of pain, infection and scarring will therefore be significantly reduced with the new proposed method. The treatment is carried out by sending focused ultrasound from the handpiece of the equipment into the target area with neurofibromas. The equipment is set to send doses of approximately 150 milliseconds (0.15 seconds). The skin area and HIFU doses can be followed on the system computer screen and will be placed side-by-side with approximately 1-2 millimeter spacing. To achieve good energy transfer from handpiece to skin, ordinary ultrasound gel is used. There are no other special pre-treatments or preparations for the process. HIFU treatment is expected to be less painful than other treatments used. The treatment is quick, and typically takes less than 1 minute for a each area the size of a typical neurofibroma.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05119582
Study type Interventional
Source Bispebjerg Hospital
Contact Joergen V Serup, Professor
Phone +45-21424888
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date March 1, 2022
Completion date January 1, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05005845 - NFX-179 Topical Gel Treatment for Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF) Phase 2
Not yet recruiting NCT04730583 - Tolerability of Device Based Therapies for Neurofibromatosis Type 1 Cutaneous Neurofibromas Phase 1
Not yet recruiting NCT03105258 - Selumetinib Pilot Study for Cutaneous Neurofibromas Phase 2
Completed NCT03090971 - Use of Topical Liquid Diclofenac Following Laser Microporation of Cutaneous Neurofibromas in Patients With NF1 Phase 2
Completed NCT04435665 - NFX-179 Topical Gel Treatment in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF) Phase 2
Active, not recruiting NCT02839720 - Selumetinib in Treating Patients With Neurofibromatosis Type 1 and Cutaneous Neurofibroma Phase 2