Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma

Christopher Zachary

Status: Enrolling

Conditions: Superficial Basal Cell Carcinoma; Nodular Basal Cell Carcinoma; Basal Cell Carcinoma

Treatments: Device: 1064 nm long-pulse Nd:YAG laser

Study type: Interventional

Funder types: Other

Identifiers

NCT04744935

20205664

Details and patient eligibility

About

Optical coherence tomography guided laser treatment of basal cell carcinoma

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Standard

Active Comparator group

Description:

1064 Long-pulse Nd:YAG laser Fluence: 120 J/cm2 Number of passes: Single Spot size: 2 cm Pulse width: 8-10 msec

Treatment:

Device: 1064 nm long-pulse Nd:YAG laser

Slow

Active Comparator group

Description:

1064 Long-pulse Nd:YAG laser Fluence: 20-30 J/cm2 Number of passes: Multiple Spot size: 2 cm Pulse width: 8-10 msec

Treatment:

Device: 1064 nm long-pulse Nd:YAG laser