New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management

Dr. Stephanie Geisler50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Basal Cell Carcinoma

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Treatment efficacy of Nd:YAG Laser 1064-nm for low risk basal cell carcinomas

Clearance rate of basal cell carcinomas after 1-3 Nd:YAG laser treatments evaluated by clinical inspectation, dermatosopy and optical coherence tomography.

Time frame: 8 weeks after the treatment

Recurrence Rate after Nd:YAG Laser treatment

To assess the recurrence rate after a long-term follow-up of 6 and 12 months

Time frame: 12 months

Secondary Outcomes

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

To assess treatment tolerability of the Nd:YAG Laser 1064-nm (e.g. pain according to a Numerical rating scale, scarring, wound healing, secondary infection rate)

Time frame: 6 and 12 months after treatment

Cosmetic outcome after laser treatment

This will be assess according to an assessment scale including following parameters: * Pigmentation: hyperpigmentation, hypopigmentation, normal * Vascularity: pink, red, purple, normal * Pliability: firm, contracture, supple, yielding, ropes, normal * Scarring: yes, no * Overall opinion: Rating on a scale from 1-5 (school note system) Separate evaluation of observer and patient.

Time frame: 6 and 12 months after treatment