High Intensity Focused Ultrasound vs. Cryotherapy in the Treatment of Basal Cell Carcinomas and Bowen's Disease in Adults

Официальное название

HIFU vs. CRYO - High Intensity Focused Ultrasound vs. Cryotherapy in the Treatment of Basal Cell Carcinomas and Bowen's Disease - a Randomized Controlled Trial

Обзор

This prospective, randomized, controlled, and single-blinded non-inferiority clinical trial compare the efficacy and tolerability of high intensity focused ultrasound (HIFU) to standard cryotherapy in the treatment of low-risk basal cell carcinomas (BCCs) and Bowen's disease (BD) in adults. The main questions it aims to answer are: * Is HIFU an efficient treatment option for BCCs and BD? * What medical problems do participants get after HIFU? Researchers will compare HIFU to standard cryotherapy with liquid nitrogen to see if the ultrasound works to treat these local and low-risk non-melanosytic skin cancers. Participants will: * Be treated either with HIFU (intervention) or cryotherapy (control). * Visit the clinic 4 weeks, 1-, 3- and 5 years after the treatment for check-ups, tests and survey questions.

Подробное описание

Low-risk BCCs and BD are both local keratinocyctic skin cancers with increasing prevalence and they cause a rising burden to the health care system. In this study we assess the efficacy of HIFU compared to liquid nitrogen cryotherapy between years 2025-2030.

Alltogether 294 patients are recruited based on referrals or from patients attending the clinic, with histologically confirmed BD, superficial BCC or nodular BCC located between neck and knees. 98 tumors of each aforementioned subtypes will be recruited and randomized with 1:1 ratio to HIFU and CRYO - groups. Follow-up appointments are 4 weeks, 1-, 3- and 5 years post treatment.

Вмешательства

• Устройство High Intensity Focused Ultrasound
  High intensity focused ultrasound
• Процедура Cryotherapy
  Liquid nitrogen cryotherapy

Первичные конечные точки

• Treatment efficacy [Срок оценки: From treatment to the end of follow up at 5 years]

Вторичные конечные точки (9)

• Pain during treatment assessed by NRS [Срок оценки: Pain during treatment procedure on treatment visit]
• Pain after treatment previous 4 weeks NRS [Срок оценки: From treatment to the control visit at 4 weeks]
• Post treatment reactions assessed by both observer and patient [Срок оценки: From treatment to the control visit at 4 weeks]
• Healing result assessed by both observer and patient [Срок оценки: From treatment to the control visit at 4 weeks]
• Healing time assessed by patient. How many weeks ago? [Срок оценки: From treatment to the control visit at 4 weeks]
• Cosmetic outcome assessed by both observer and the patient [Срок оценки: From 1 year control to the end of follow up at 5 years]
• Patient satisfaction inquiry, modified 6 questions [Срок оценки: From 1 year control to the end of follow up at 5 years]
• Scarring after treatment POSAS 2.0 [Срок оценки: From 1 year control to the end of follow up at 5 years]
• Other adverse events related to the given treatment [Срок оценки: From treatment visit to the end of follow up at 5 years]

Критерии участия

Критерии включения

• age 18 years or older at the time of informed consent
• ability to give informed consent and comply with the treatment protocol and follow-up plan
• study lesion located between neck and knees
• one of following histologically confirmed diagnosis: Superficial BCC with maximum diameter of 2.0 cm / Nodular BCC with max. diameter of 1.5 cm / BD with max. diameter of 2.0 cm

Критерии исключения

• Study lesion location in face, head, genitals, hands, or below the knee
• Clinical/dermoscopical/histological feature for high-risk/aggressive BCC
• Clinical/histological sign for hypertrophic BD
• Clinical/dermoscopical/histological feature for Squamous cell carcinoma
• Gorlin Golz syndrome
• Pregnancy or breastfeeding

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Финляндия · 1 центр

• HUS Iho- ja allergiasairaala — Helsinki

Публикации

• The Finnish Cancer Registry; Syöpätilastosovellus. Vuosiraportti 2023. [Internet]. [cited 2025 Nov 19]. Available from: https://syoparekisteri.fi/tilastot/tautitilastot/
• Schlessinger DI, Reynolds KA, Dirr MA, Ibrahim SA, Yanes AF, Lazaroff JM, Godinez-Puig V, Chen BR, Kurta AO, Cotseones JK, Chiren SG, Furlan KC, Iyengar S, Behshad R, DeHoratius DM, Denes P, Drucker AM, Dzubow LM, Etzkorn JR, Harwood CA, Kim JYS, Lawrence N, Lee EH, Lissner GS, Marghoob AA, Matin RN, Mattox AR, Mittal BB, Thomas JR, Zhou XA, Zloty D, Schmitt J, Kirkham JJ, Armstrong AW, Basset-Seg PMID 35551965
• Hansen JP, Drake AL, Walling HW. Bowen's Disease: a four-year retrospective review of epidemiology and treatment at a university center. Dermatol Surg. 2008 Jul;34(7):878-83. doi: 10.1111/j.1524-4725.2008.34172.x. PMID 18363722
• Wang I, Bendsoe N, Klinteberg CA, Enejder AM, Andersson-Engels S, Svanberg S, Svanberg K. Photodynamic therapy vs. cryosurgery of basal cell carcinomas: results of a phase III clinical trial. Br J Dermatol. 2001 Apr;144(4):832-40. doi: 10.1046/j.1365-2133.2001.04141.x. PMID 11298545
• Basset-Seguin N, Ibbotson SH, Emtestam L, Tarstedt M, Morton C, Maroti M, Calzavara-Pinton P, Varma S, Roelandts R, Wolf P. Topical methyl aminolaevulinate photodynamic therapy versus cryotherapy for superficial basal cell carcinoma: a 5 year randomized trial. Eur J Dermatol. 2008 Sep-Oct;18(5):547-53. doi: 10.1684/ejd.2008.0472. Epub 2008 Aug 8. PMID 18693158
• Seppä K, Lappi-Heikkinen S, Johansson S, Malila N, Pitkäniemi J. SYÖPÄ 2023 Tilastoraportti Suomen syöpätilanteesta. Suomen Syöpäyhdistys, Helsinki 2025.
• Keratinocyte Cancer Clinical Guidelines | Cancer Council [Internet]. [cited 2025 Nov 19]. Available from: https://www.cancer.org.au/clinical-guidelines/skin-cancer/keratinocyte-cancer
• Telfer NR, Colver GB, Morton CA; British Association of Dermatologists. Guidelines for the management of basal cell carcinoma. Br J Dermatol. 2008 Jul;159(1):35-48. doi: 10.1111/j.1365-2133.2008.08666.x. PMID 18593385

Идентификаторы

NCT: NCT07384078 · HUS/6520/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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