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Laser Treatment of Basal Cell Carcinoma Under Imaging Guidance

Primary Purpose

Carcinoma, Basal Cell

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment of basal cell carcinoma with Nd:YAG laser under imaging guidance of optical coherence tomography (OCT)
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Basal Cell focused on measuring Optical coherence tomography, reflectance confocal microscopy

Eligibility Criteria

18 Years - 105 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 or older
  • At least one (1) biopsy-proven superficial or nodular BCC, less than or equal to 2.0 cm in largest dimension
  • Willing to have photographs taken of the treatment area
  • Ability to understand and carry out subject instructions or be represented by a legally authorized guardian or representative

Exclusion Criteria:

  • Pregnancy
  • Patients with a BCC lesion that requires excision. This would include relatively large lesions (greater than or equal to >2.0 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.
  • Subjects unable to follow-up for the full 12 months
  • Subjects not willing to have biopsy taken from the treatment area
  • Subjects with herpes simplex virus infection in treatment areas.

Sites / Locations

  • Henry Ford Health SystemRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment of basal cell carcinoma with Nd:YAG laser

Arm Description

All enrolled patients will be treated with the Nd:YAG laser for this study as part of the intentional intervention for this study.

Outcomes

Primary Outcome Measures

Clearance by imaging
Clearance of BCC as indicated by imaging of optical coherence tomography (OCT)
Clearance by biopsy
Clearance of BCC as indicated by biopsy

Secondary Outcome Measures

Full Information

First Posted
November 17, 2021
Last Updated
February 2, 2023
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT05138328
Brief Title
Laser Treatment of Basal Cell Carcinoma Under Imaging Guidance
Official Title
Laser Treatment of Basal Cell Carcinoma Under Imaging Guidance
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This pilot study will examine the treatment of basal cell carcinoma (BCC) with laser technology under the guidance of imaging modalities to assist with surgical excision, including optical coherence tomography imaging (OCT) and reflectance confocal microscopy (RCM). The laser modality that we plan to use is the long-pulse Nd:YAG 1064nm laser, which is a nonablative laser already shown to effectively treat BCC. The addition of OCT and RCM has the opportunity to enhance outcomes by better targeting the treatment and permitting more precise monitoring of clearance. OCT is being used to enhance the effectiveness of Mohs Micrographic Surgery of these cancers by elucidating more definitive tumor margins. RCM has been shown to detect changes in the composition of cells consistent with BCC. We propose to use these imaging devices to guide the laser treatment to achieve optimal efficacy with minimized side-effects. Primary outcome measured include complete clearance of the BCC lesion, which will be determined through clinical examination, dermoscopy, imaging (OCT and/or RCM), and saucerization biopsy. Secondary outcome variables include the significance of lesion depth (by OCT and/or RCM), lateral extent (by OCT and/or RCM), BCC type, and anatomical region on rate of clearance and recurrence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Basal Cell
Keywords
Optical coherence tomography, reflectance confocal microscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment of basal cell carcinoma with Nd:YAG laser
Arm Type
Experimental
Arm Description
All enrolled patients will be treated with the Nd:YAG laser for this study as part of the intentional intervention for this study.
Intervention Type
Device
Intervention Name(s)
Treatment of basal cell carcinoma with Nd:YAG laser under imaging guidance of optical coherence tomography (OCT)
Intervention Description
This will use optical coherence tomography (OCT) to assess the margins of basal cell carcinoma. Treatment will be completed by Nd:YAG laser.
Primary Outcome Measure Information:
Title
Clearance by imaging
Description
Clearance of BCC as indicated by imaging of optical coherence tomography (OCT)
Time Frame
3-15 months after treatment
Title
Clearance by biopsy
Description
Clearance of BCC as indicated by biopsy
Time Frame
3-15 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or older At least one (1) biopsy-proven superficial or nodular BCC, less than or equal to 2.0 cm in largest dimension Willing to have photographs taken of the treatment area Ability to understand and carry out subject instructions or be represented by a legally authorized guardian or representative Exclusion Criteria: Pregnancy Patients with a BCC lesion that requires excision. This would include relatively large lesions (greater than or equal to >2.0 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. Subjects unable to follow-up for the full 12 months Subjects not willing to have biopsy taken from the treatment area Subjects with herpes simplex virus infection in treatment areas.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Creasor
Phone
3136769672
Email
jcreaso2@hfhs.org
First Name & Middle Initial & Last Name or Official Title & Degree
David Ozog
Email
dozog1@hfhs.org
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Creasor
Phone
313-676-9672

12. IPD Sharing Statement

Plan to Share IPD
No

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Laser Treatment of Basal Cell Carcinoma Under Imaging Guidance

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