New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management

Dr. Stephanie Geisler

Status: Not yet enrolling

Conditions: Basal Cell Carcinoma

Treatments: Device: Cynosure Cynergy Nd:YAG Laser 1064nm

Study type: Interventional

Funder types: Other

Identifiers

NCT05324202

Ndyag_BCC_1

Details and patient eligibility

About

The aim of this study is to show that the Nd:YAG laser could be a promising alternative treatment option in the management of low-risk basal cell carcinomas with similar high efficacy rates to surgery, and low recurrence rates evaluated over a time period of one year. Reflectance confocal microscopy, optical coherence tomography and clinical examination are used prior to confirm the clinical diagnosis of the basal cell carcinoma and for premargination of the tumor. The optical coherence tomography will also be used post treatment to confirm clearance of the basal cell carcinoma and to monitor treatment response.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Patients with one or more basal cell carcinoma(s) on head, trunk or extremities

• Diagnosed clinically, with a dermatoscope and through noninvasive imaging methods such as reflectance confocal microscopy and optical coherence tomography
• H zone <6mm, M zone <10mm, L zone <20mm
• Tumor thickness <2mm
• Clearly visible margins

Exclusion criteria

• Pregnancy
• <18 years of age
• Current or history of immunosuppression
• Prior-treatment of the basal cell carcinoma/ recurrent basal cell carcinomas
• History of radiation in the area of basal cell carcinoma appearance

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Nd:YAG treatment arm

Other group

Treatment:

Device: Cynosure Cynergy Nd:YAG Laser 1064nm