Laser Treatment of Basal Cell Carcinoma Under Imaging Guidance

NCT05138328 | Completed FDA Device

• 1 other identifier: 14488
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carcinoma, Basal Cell

Keywords

Optical coherence tomography, reflectance confocal microscopy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Treatment of basal cell carcinoma with Nd:YAG laser

EXPERIMENTAL

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)

Interventions

Treatment of basal cell carcinoma with Nd:YAG laser under imaging guidance of optical coherence tomography (OCT) DEVICE

This will use optical coherence tomography (OCT) to assess the margins of basal cell carcinoma. Treatment will be completed by Nd:YAG laser.

Treatment of basal cell carcinoma with Nd:YAG laser

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Dermatology

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: November 30, 2021
• Study Start: June 12, 2021
• Primary Completion: May 12, 2023
• Study Completion: May 12, 2023
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)