NCT05138328

Laser Treatment of Basal Cell Carcinoma Under Imaging Guidance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years – 105 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-12
• Primary completion: 2023-05-12
• Completion: 2023-05-12
• First posted: 2021-11-30
• Last updated: 2025-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study