Laser Treatment of Basal Cell Carcinoma Under Imaging Guidance

This pilot study will examine the treatment of basal cell carcinoma (BCC) with laser technology under the guidance of imaging modalities to assist with surgical excision, including optical coherence tomography imaging (OCT) and reflectance confocal microscopy (RCM). The laser modality that we plan to use is the long-pulse Nd:YAG 1064nm laser, which is a nonablative laser already shown to effectively treat BCC. The addition of OCT and RCM has the opportunity to enhance outcomes by better targeting the treatment and permitting more precise monitoring of clearance. OCT is being used to enhance the effectiveness of Mohs Micrographic Surgery of these cancers by elucidating more definitive tumor margins. RCM has been shown to detect changes in the composition of cells consistent with BCC.

We propose to use these imaging devices to guide the laser treatment to achieve optimal efficacy with minimized side-effects. Primary outcome measured include complete clearance of the BCC lesion, which will be determined through clinical examination, dermoscopy, imaging (OCT and/or RCM), and saucerization biopsy. Secondary outcome variables include the significance of lesion depth (by OCT and/or RCM), lateral extent (by OCT and/or RCM), BCC type, and anatomical region on rate of clearance and recurrence.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Basal Cell
• Intervention / Treatment: Device: Treatment of basal cell carcinoma with Nd:YAG laser under imaging guidance of optical coherence tomography (OCT)

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 101 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 or older
• At least one (1) biopsy-proven superficial or nodular BCC, less than or equal to 2.0 cm in largest dimension
• Willing to have photographs taken of the treatment area
• Ability to understand and carry out subject instructions or be represented by a legally authorized guardian or representative

Exclusion Criteria:

• Pregnancy
• Patients with a BCC lesion that requires excision. This would include relatively large lesions (greater than or equal to >2.0 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.
• Subjects unable to follow-up for the full 12 months
• Subjects not willing to have biopsy taken from the treatment area
• Subjects with herpes simplex virus infection in treatment areas.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment of basal cell carcinoma with Nd:YAG laser; All enrolled patients will be treated with the Nd:YAG laser for this study as part of the intentional intervention for this study.	Device: Treatment of basal cell carcinoma with Nd:YAG laser under imaging guidance of optical coherence tomography (OCT); This will use optical coherence tomography (OCT) to assess the margins of basal cell carcinoma. Treatment will be completed by Nd:YAG laser.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clearance by imaging	Clearance of BCC as indicated by imaging of optical coherence tomography (OCT)	3-15 months after treatment
Clearance by biopsy	Clearance of BCC as indicated by biopsy	3-15 months after treatment

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2021
• Primary Completion (Actual): May 12, 2023
• Study Completion (Actual): May 12, 2023

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Optical coherence tomography, reflectance confocal microscopy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell
• Other Study ID Numbers: 14488

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