New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management

Basal Cell Carcinoma Clinical Trial

Official title:

New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05324202
• Other study ID #: Ndyag_BCC_1
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: April 2023

Study information

• Verified date: April 2022
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Intervention

Device:
• Cynosure Cynergy Nd:YAG Laser 1064nm
The Nd:YAG Laser 1064nm is intended to be used as a treatment option in individuals suffering from low-risk basal cell carcinoma(s).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Stephanie Geisler

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks after the treatment
Primary	Recurrence Rate after Nd:YAG Laser treatment	To assess the recurrence rate after a long-term follow-up of 6 and 12 months	12 months
Secondary	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)	6 and 12 months after treatment
Secondary	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.	6 and 12 months after treatment