Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging

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

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-30

Study Completion Date

2017-12-01

Brief Summary

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The use of MDS to access the presence of melanoma in the skin.

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Detailed Description

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A topical agent is applied to suspicious skin lesions and imaged. The images are analyzed to provide a score that correlates with the probability for the presence of melanoma in the lesion.

Conditions

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Skin Lesion

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Suspicious skin lesions.

Patients with a suspicious skin lesion referred for a biopsy are tested using MDS

MDS

Intervention Type DEVICE

Patients with a suspicious lesion, referred for a biopsy is tested using MDS.

Interventions

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MDS

Patients with a suspicious lesion, referred for a biopsy is tested using MDS.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Individuals with skin lesion with one or more of the ABCDE features and recommended for a skin biopsy.
* The lesion is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS.
* Male and female ≥ 21 years old.
* Subject is capable of giving written informed consent.
* Primary excision.

Exclusion Criteria

* The lesion is less than 1 cm from the eyes.
* The lesion is on the palms of hands or soles of the feet.
* Mucosal lesion.
* Pregnant females.
* Low study procedure compliance.
* Patients who are mentally or physically unable to comply with all aspects of the study.
* Undergoing chemotherapy.
* Minor or legally incompetent and not able to sign the consent form.
* Patient previously tested by MDS and was diagnosed with melanoma during the study.
* Sensitivity to fluorescein

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No