HIFU vs. CRYO - High Intensity Focused Ultrasound vs. Cryotherapy in the Treatment of Basal Cell Carcinomas and Bowen's Disease - a Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Jussi Salonen
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- Treatment efficacy
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
sBCC
Superficial basal cell carcinoma
干预措施: High Intensity Focused Ultrasound (Device)
sBCC
Superficial basal cell carcinoma
干预措施: Cryotherapy (Procedure)
nBCC
Nodular basal cell carcinoma
干预措施: High Intensity Focused Ultrasound (Device)
nBCC
Nodular basal cell carcinoma
干预措施: Cryotherapy (Procedure)
BD
Bowen's disease
干预措施: High Intensity Focused Ultrasound (Device)
BD
Bowen's disease
干预措施: Cryotherapy (Procedure)
结局指标
主要结局
Treatment efficacy
时间窗: From treatment to the end of follow up at 5 years
Histologically confirmed recurrence-free survival assessed at 1, 3 and 5 years after treatment. Recurrence during follow up: Yes/no.
次要结局
- Pain during treatment assessed by NRS(Pain during treatment procedure on treatment visit)
- Pain after treatment previous 4 weeks NRS(From treatment to the control visit at 4 weeks)
- Post treatment reactions assessed by both observer and patient(From treatment to the control visit at 4 weeks)
- Healing result assessed by both observer and patient(From treatment to the control visit at 4 weeks)
- Healing time assessed by patient. How many weeks ago?(From treatment to the control visit at 4 weeks)
- Cosmetic outcome assessed by both observer and the patient(From 1 year control to the end of follow up at 5 years)
- Patient satisfaction inquiry, modified 6 questions(From 1 year control to the end of follow up at 5 years)
- Scarring after treatment POSAS 2.0(From 1 year control to the end of follow up at 5 years)
- Other adverse events related to the given treatment(From treatment visit to the end of follow up at 5 years)
研究者
Jussi Salonen
Clinical Investigator
Helsinki University Central Hospital