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OpenTrials
Completed

NCT Number: NCT02009085

Pilot Study to Determine Feasibility of Benign and Malignant Skin Lesion Detection.

In this study a fluorescent contrast dye is applied to a suspicious skin lesion.

Images are acquired and processed. The information is used to develop a prediction model for the presence of malignant transformation in the skin.

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Key information

Conditions

Skin Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Images acquired in the study are used for the development of a software analysis program.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over the age of 18
  • Individual is scheduled for a skin biopsy in toto
  • The lesion is pigmented or non pigmented
  • Lesions may be under suspicion for basal cell carcinoma, squamous cell carcinoma, actinic keratosis, nevi, melanoma, seborrheic keratosis.
  • The lesion is accessible to the imaging device

Exclusion criteria

  • The patient has sensitive skin and easily breaks out in rash
  • The lesion is within 1 cm of the eye
  • The lesion is on mucosal surfaces (e.g., lips, genitals)
  • Pregnant females
  • Taking medications that pigments the skin

Treatment and study plan

Primary outcomes

  1. Correlation between imaging and pathology.

    Time frame: No long term follow up is necessary.

    Patients are imaged and then undergo a biopsy. Images are used to develop a software predicting model based on pathology. Sensitivity and specificity parameters are calculated.

    No long term follow up is required since the biopsy is performed on the skin imaged. The follow up required is for the pathology for the skin excised.

Secondary outcomes

  1. Acute response

    Time frame: up to 1 day

    The acute dermal response to the imaging procedure is evaluated.

Other outcomes

  1. None specified.

    no other outcome is specified in the .

Sponsors and collaborators

Lead sponsor

Orlucent, Inc

Industry

Collaborators

  • Clalit Health Services

Registry information

Official study title

Pilot Study to Asses the Identification of Melanoma in Skin Lesions.

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 11, 2013
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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