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Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT04744935
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine

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

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Superficial Basal Cell Carcinoma Nodular Basal Cell Carcinoma Device: 1064 nm long-pulse Nd:YAG laser Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma
Actual Study Start Date : January 13, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard
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
BCC lesion will be treated with long-pulse 1064 laser, with surface temperature monitored by infrared camera.
Active Comparator: 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
 Device: 1064 nm long-pulse Nd:YAG laser
BCC lesion will be treated with long-pulse 1064 laser, with surface temperature monitored by infrared camera.


Outcome Measures
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Primary Outcome Measures :
  1. Complete clearance of BCC lesion [ Time Frame: 1 year ]
    Those whose lesion is not in a cosmetically sensitive area will undergo a skin biopsy for histological confirmation of OCT results.


Secondary Outcome Measures :
  1. Cosmetic outcome [ Time Frame: 1 year ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04744935


Contacts
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Contact: Erica G Baugh 6027430096 ebaugh@hs.uci.edu

Locations
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United States, California
UCI Health Gottschalk Medical Plaza Recruiting
Irvine, California, United States, 92617
Contact: Erica G Baugh         
Principal Investigator: Christopher B Zachary, MD         
Sponsors and Collaborators
University of California, Irvine
More Information
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Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT04744935    
Other Study ID Numbers: 2020-5664
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of California, Irvine:
Basal cell carcinoma
Superficial basal cell carcinoma
Nodular basal cell carcinoma
 Optical coherence tomography
OCT
Laser
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell