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NCT04744935 | RECRUITING | Basal Cell Carcinoma


Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma
Sponsor:

Christopher Zachary

Information provided by (Responsible Party):

Christopher Zachary

Brief Summary:

Optical coherence tomography guided laser treatment of basal cell carcinoma

Condition or disease

Basal Cell Carcinoma

Superficial Basal Cell Carcinoma

Nodular Basal Cell Carcinoma

Intervention/treatment

1064 nm long-pulse Nd:YAG laser

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma
Actual Study Start Date : 2021-01-13
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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.

Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma

Location Details

NCT04744935


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Locations


RECRUITING

United States, California

UCI Health Gottschalk Medical Plaza

Irvine, California, United States, 92617

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