Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-13

Study Completion Date

2025-12-31

Brief Summary

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Optical coherence tomography guided laser treatment of basal cell carcinoma

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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.

Conditions

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Basal Cell Carcinoma Superficial Basal Cell Carcinoma Nodular Basal Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard

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

Group Type ACTIVE_COMPARATOR

1064 nm long-pulse Nd:YAG laser

Intervention Type DEVICE

BCC lesion will be treated with long-pulse 1064 laser, with surface temperature monitored by infrared camera.

Slow

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

Group Type ACTIVE_COMPARATOR

1064 nm long-pulse Nd:YAG laser

Intervention Type DEVICE

BCC lesion will be treated with long-pulse 1064 laser, with surface temperature monitored by infrared camera.

Interventions

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1064 nm long-pulse Nd:YAG laser

BCC lesion will be treated with long-pulse 1064 laser, with surface temperature monitored by infrared camera.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes