Laser Treatment of Basal Cell Carcinoma Under Imaging Guidance

Carcinoma, Basal Cell Clinical Trial

Official title:

Laser Treatment of Basal Cell Carcinoma Under Imaging Guidance

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05138328
• Other study ID #: 14488
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 3, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell

Intervention

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.

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearance by imaging	Clearance of BCC as indicated by imaging of optical coherence tomography (OCT)	3-15 months after treatment
Primary	Clearance by biopsy	Clearance of BCC as indicated by biopsy	3-15 months after treatment