Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma

Study Overview
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Brief Summary
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Optical coherence tomography guided laser treatment of basal cell carcinoma

Detailed Description
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The purpose of this pilot study is to examine the treatment basal cell carcinoma (BCC) with laser technology under the guidance of optical coherence tomography imaging (OCT). The laser modality that we plan to use is the long-pulse Nd:YAG 1064nm laser, which is a non-ablative laser already shown to effectively treat BCC. Laser treatment of BCC has limited precedent in the literature, but the addition of OCT has the opportunity to enhance outcomes by better targeting the treatment and permitting more precise monitoring of clearance. We propose to use OCT imaging to guide the laser treatment to achieve optimal efficacy with minimized side-effects.

Official Title
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Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma

Conditions
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Basal Cell Carcinoma, Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma

Intervention / Treatment
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* Device: 1064 nm long-pulse Nd:YAG laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand and carry out subject instructions or be represented by a legally authorized guardian or representative Ages 18 and older Seeks and is scheduled for treatment of a BCC previously confirmed with biopsy Exclusion Criteria: Any of the following will exclude participation in the study: Inability to understand and/or carry out instructions Patients with a BCC lesion that requires excision. This would include relatively large lesions (>2.5 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. Patients with periocular BCCs which might expose the patient to risk of damage to eyes from the laser. BCCs on legs due to their tendency towards poor wound healing. Pregnancy Patients unable to follow-up for the full 12 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>1064 Long-pulse Nd:YAG laser Fluence: 120 J/cm2 Number of passes: Single Spot size: 2 cm Pulse width: 8-10 msec | Device: 1064 nm long-pulse Nd:YAG laser<br>* BCC lesion will be treated with long-pulse 1064 laser, with surface temperature monitored by infrared camera.<br>|
| Active Comparator: Slow<br>1064 Long-pulse Nd:YAG laser Fluence: 20-30 J/cm2 Number of passes: Multiple Spot size: 2 cm Pulse width: 8-10 msec | Device: 1064 nm long-pulse Nd:YAG laser<br>* BCC lesion will be treated with long-pulse 1064 laser, with surface temperature monitored by infrared camera.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete clearance of BCC lesion | Those whose lesion is not in a cosmetically sensitive area will undergo a skin biopsy for histological confirmation of OCT results. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic outcome | We assess cosmetic outcome and any adverse effects of the laser treatment as a result of the laser treatment, rated on a 0-4 Likert scaleworst cosmetic outcome and 4 resembling normal skin, upon follow-up of treatment. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCT, Laser, Basal cell carcinoma, Superficial basal cell carcinoma, Nodular basal cell carcinoma, Optical coherence tomography