Optical Coherence Tomography Guided C&D

NCT ID: NCT04510727

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-02-01

Brief Summary

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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).

Detailed Description

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Conditions

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Basal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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OCT Guided C&D Group

Participants in this group will receive OCT imaging immediately prior, immediately after and 2 months after post standard of care C\&D.

Group Type EXPERIMENTAL

Optical Coherence Tomography (OCT)

Intervention Type DEVICE

VivoSight Dx OCT system from Michelson Diagnostics Ltd. OCT will be used to visualize the tumor and lesion in the skin.

Curettage & Desiccation (C&D) Procedure

Intervention Type PROCEDURE

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.

Interventions

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Optical Coherence Tomography (OCT)

VivoSight Dx OCT system from Michelson Diagnostics Ltd. OCT will be used to visualize the tumor and lesion in the skin.

Intervention Type DEVICE

Curettage & Desiccation (C&D) Procedure

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Keyvan Nouri

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keyvan Nouri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Maria V Muniz

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20200212

Identifier Type: -

Identifier Source: org_study_id

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