Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma

Optical coherence tomography guided laser treatment of basal cell carcinoma

Study Overview

• Status: Active, not recruiting
• Conditions: Basal Cell Carcinoma; Nodular Basal Cell Carcinoma; Superficial Basal Cell Carcinoma
• Intervention / Treatment: Device: 1064 nm long-pulse Nd:YAG laser

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92617
      • UCI Health Dermatology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard; 1064 Long-pulse Nd:YAG laser Fluence: 120 J/cm2 Number of passes: Single Spot size: 2 cm Pulse width: 8-10 msec	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.
Active Comparator: Slow; 1064 Long-pulse Nd:YAG laser Fluence: 20-30 J/cm2 Number of passes: Multiple Spot size: 2 cm Pulse width: 8-10 msec	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete histological 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Christopher Zachary
• Investigators: Principal Investigator: Christopher Zachary, MBBS FRCP, University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2021
• Primary Completion (Estimated): February 17, 2027
• Study Completion (Estimated): February 17, 2027

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: OCT; Optical coherence tomography; Nodular basal cell carcinoma; Laser; Basal cell carcinoma; Superficial basal cell carcinoma
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Neoplasms, Basal Cell; Carcinoma, Basal Cell
• Other Study ID Numbers: 20205664

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes