Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma

Not Applicable

Recruiting

• Conditions: Basal Cell Carcinoma; Nodular Basal Cell Carcinoma; Superficial Basal Cell Carcinoma

• Registration Number: NCT04744935
• Lead Sponsor: Christopher Zachary

Brief Summary

Optical coherence tomography guided laser treatment of basal cell carcinoma

Detailed 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.

Study Timeline

• Study Start: 2021-01-13
• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-26
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Complete clearance of BCC lesion	1 year	Those whose lesion is not in a cosmetically sensitive area will undergo a skin biopsy for histological confirmation of OCT results.

Secondary Outcome Measures

Name	Time	Method
Cosmetic outcome	1 year	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.

Trial Locations

Locations (1)

UCI Health Gottschalk Medical Plaza; 🇺🇸 Irvine, California, United States