Clinical trial NCT05138328: Laser Treatment of Basal Cell Carcinoma Under Imaging Guidance
Official title: Laser Treatment of Basal Cell Carcinoma Under Imaging Guidance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Basal Cell
Keywords: Optical coherence tomography, reflectance confocal microscopy
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clearance by imaging
timeFrame: 3-15 months after treatment
measure: Clearance by biopsy
timeFrame: 3-15 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References: