Back to resultsOptical Coherence Tomography Guided C&D
Primary Purpose
Basal Cell Carcinoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optical Coherence Tomography (OCT)
Curettage & Desiccation (C&D) Procedure
Sponsored by
About this trial
This is an interventional diagnostic trial for Basal Cell Carcinoma focused on measuring Superficial basal cell carcinoma, Nodular basal cell carcinoma
Eligibility Criteria
Inclusion Criteria:
- Patients of any: age, gender, Fitzpatrick skin type and ethnicity.
- Primary BCC of any type, except aggressive types that fit the criteria for Mohs surgery
- No prior treatment on the lesion within the last 3 months.
- Lesions anywhere except the head, neck and distal extremities.
- Willing and able to sign informed consent
Exclusion Criteria:
- Aggressive BCC types.
- Recurrent tumors.
- Lesion treated within last 3 months.
- Lesions on head and neck (high risk areas)
- Lesions on distal extremities (thin epidermis not preferred for OCT).
- Pregnant women.
- Patients less than 18 years old.
- Prisoners.
- Any other condition or circumstance that, in the opinion of the Investigator, may compromise the subject's ability to comply with the study protocol
Sites / Locations
- Maria V Muniz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OCT Guided C&D Group
Arm Description
Participants in this group will receive OCT imaging immediately prior, immediately after and 2 months after post standard of care C&D.
Outcomes
Primary Outcome Measures
The incidence of residual basal cell carcinoma tumor cells
The incidence of residual superficial and nodular basal cell carcinoma tumor cells after standard of care C&D as assessed using the OCT.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04510727
Brief Title
Optical Coherence Tomography Guided C&D
Official Title
Using OCT Imaging to Determine the Presence of Residual Tumor Cells After C&D for Superficial and Nodular BCC: A Prospective Study.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to identify the presence of residual superficial and nodular basal cell carcinoma (BCC) status-post curettage and desiccation (C&D) by using optical coherence tomography (OCT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma
Keywords
Superficial basal cell carcinoma, Nodular basal cell carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OCT Guided C&D Group
Arm Type
Experimental
Arm Description
Participants in this group will receive OCT imaging immediately prior, immediately after and 2 months after post standard of care C&D.
Intervention Type
Device
Intervention Name(s)
Optical Coherence Tomography (OCT)
Intervention Description
VivoSight Dx OCT system from Michelson Diagnostics Ltd. OCT will be used to visualize the tumor and lesion in the skin.
Intervention Type
Procedure
Intervention Name(s)
Curettage & Desiccation (C&D) Procedure
Intervention Description
Standard of care C&D where the basal cell carcinoma lesion will be scraped to its base using a Fox dermal curette and an electrodesiccation machine.
Primary Outcome Measure Information:
Title
The incidence of residual basal cell carcinoma tumor cells
Description
The incidence of residual superficial and nodular basal cell carcinoma tumor cells after standard of care C&D as assessed using the OCT.
Time Frame
2 months (post C&D procedure)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of any: age, gender, Fitzpatrick skin type and ethnicity.
Primary BCC of any type, except aggressive types that fit the criteria for Mohs surgery
No prior treatment on the lesion within the last 3 months.
Lesions anywhere except the head, neck and distal extremities.
Willing and able to sign informed consent
Exclusion Criteria:
Aggressive BCC types.
Recurrent tumors.
Lesion treated within last 3 months.
Lesions on head and neck (high risk areas)
Lesions on distal extremities (thin epidermis not preferred for OCT).
Pregnant women.
Patients less than 18 years old.
Prisoners.
Any other condition or circumstance that, in the opinion of the Investigator, may compromise the subject's ability to comply with the study protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Muniz
Phone
305-689-2646
Email
mmuniz@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keyvan Nouri, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria V Muniz
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria V Muniz
Phone
305-689-2646
Email
mmuniz@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Keyvan Nouri, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Optical Coherence Tomography Guided C&D
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