Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma
Primary Purpose
Basal Cell Carcinoma, Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1064 nm long-pulse Nd:YAG laser
Sponsored by
About this trial
This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring Basal cell carcinoma, Superficial basal cell carcinoma, Nodular basal cell carcinoma, Optical coherence tomography, OCT, Laser
Eligibility 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.
Sites / Locations
- UCI Health Gottschalk Medical PlazaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard
Slow
Arm Description
1064 Long-pulse Nd:YAG laser Fluence: 120 J/cm2 Number of passes: Single Spot size: 2 cm Pulse width: 8-10 msec
1064 Long-pulse Nd:YAG laser Fluence: 20-30 J/cm2 Number of passes: Multiple Spot size: 2 cm Pulse width: 8-10 msec
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04744935
Brief Title
Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma
Official Title
Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christopher Zachary
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Optical coherence tomography guided laser treatment of basal cell carcinoma
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma, Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma
Keywords
Basal cell carcinoma, Superficial basal cell carcinoma, Nodular basal cell carcinoma, Optical coherence tomography, OCT, Laser
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
1064 Long-pulse Nd:YAG laser Fluence: 120 J/cm2 Number of passes: Single Spot size: 2 cm Pulse width: 8-10 msec
Arm Title
Slow
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
1064 nm long-pulse Nd:YAG laser
Intervention Description
BCC lesion will be treated with long-pulse 1064 laser, with surface temperature monitored by infrared camera.
Primary Outcome Measure Information:
Title
Complete clearance of BCC lesion
Description
Those whose lesion is not in a cosmetically sensitive area will undergo a skin biopsy for histological confirmation of OCT results.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Cosmetic outcome
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel A Elsanadi
Phone
9492359217
Email
relsanad@hs.uci.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Zachary, MBBS FRCP
Organizational Affiliation
Department of Dermatology, University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCI Health Gottschalk Medical Plaza
City
Irvine
State/Province
California
ZIP/Postal Code
92617
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel A Elsanadi
First Name & Middle Initial & Last Name & Degree
Christopher B Zachary, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma
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