Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma

Basal Cell Carcinoma Clinical Trial

Official title:

Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04744935
• Other study ID #: 20205664
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: University of California, Irvine
• Contact: Feben Messele
• Phone: 949-824-5515
• Email: fmessele[@]hs.uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Optical coherence tomography guided laser treatment of basal cell carcinoma

Description:

The purpose of this pilot study is to examine the treatment basal cell carcinoma (BCC) with laser technology under the guidance of optical coherence tomography imaging (OCT). The laser modality that we plan to use is the long-pulse Nd:YAG 1064nm laser, which is a non-ablative laser already shown to effectively treat BCC. Laser treatment of BCC has limited precedent in the literature, but the addition of OCT has the opportunity to enhance outcomes by better targeting the treatment and permitting more precise monitoring of clearance. We propose to use OCT imaging to guide the laser treatment to achieve optimal efficacy with minimized side-effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Ability to understand and carry out subject instructions or be represented by a legally authorized guardian or representative

• Ages 18 and older

• Seeks and is scheduled for treatment of a BCC previously confirmed with biopsy

Exclusion Criteria:

Any of the following will exclude participation in the study:

• Inability to understand and/or carry out instructions

• Patients with a BCC lesion that requires excision. This would include relatively large lesions (>2.5 cm diameter), lesions that penetrate deep into the skin beyond the depth of the OCT image capture, high risk lesions as defined by the American Academy of Dermatology as recurrent and sclerosing subtype BCC, or metastases.

• Patients with periocular BCCs which might expose the patient to risk of damage to eyes from the laser.

• BCCs on legs due to their tendency towards poor wound healing.

• Pregnancy

• Patients unable to follow-up for the full 12 months.

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Nodular Basal Cell Carcinoma
• Superficial Basal Cell Carcinoma

Intervention

Device:
• 1064 nm long-pulse Nd:YAG laser
BCC lesion will be treated with long-pulse 1064 laser, with surface temperature monitored by infrared camera.

Locations

Country	Name	City	State
United States	UCI Health Gottschalk Medical Plaza	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Christopher Zachary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete clearance of BCC lesion	Those whose lesion is not in a cosmetically sensitive area will undergo a skin biopsy for histological confirmation of OCT results.	1 year
Secondary	Cosmetic outcome	We assess cosmetic outcome and any adverse effects of the laser treatment as a result of the laser treatment, rated on a 0-4 Likert scaleworst cosmetic outcome and 4 resembling normal skin, upon follow-up of treatment.	1 year