Using High Resolution Function Imaging To Detect Melanoma and Dysplastic Nevi

February 6, 2019 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
A novel infrared imaging tool to aid in the clinical detection of atypical pigmented lesions and melanoma is developed. Goals include evaluation of the utility of high-resolution infrared scanning of cutaneous lesions in the diagnosis of pigmented lesions and the identification of high-risk lesions and melanomas.

Study Overview

Status

Completed

Conditions

Detailed Description

This study uses a specific skin protocol to cool the skin and then measures the cutaneous thermal recovery to uniquely identify lesions that may be cancerous. Using computer models, the thermal signature is used to determine the size and shape of the lesions in question. In particular, this study seeks to add quantification analysis of high resolution thermal images of melanoma lesions to provide accurate early diagnostic capability with specific detail regarding size, shape and depth of the lesions. This information will be compared to biopsy results and surgical resection results.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The subject population will be identified in the Department of Dermatology Pigmented Lesion Clinic at the Johns Hopkins Hospital Outpatient Center. Recruited patients will only comprise those requesting a cutaneous pigmented lesion removed or patients that are examined and found to have a pigmented lesion that is suspicious for malignancy at the time of their visit, and thus recommended to have a skin biopsy for diagnosis following the standard of care

Description

Inclusion Criteria:

  • Patients seen in the high-risk pigmented lesion clinic, who posses a pigmented lesion with a clinical indication for biopsy

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability to Detect of the melanoma lesions
Time Frame: up to 2 years
Using activated cooling methods we are measuring skin surface temperature recovery of specific lesions and comparing them to biopsy results of the lesions in question.
up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement of thermal signatures of benign cutaneous lesions
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Johns Hopkins University
National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Cila Herman, Dr-Ing., Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2009

Primary Completion (Actual)

June 29, 2010

Study Completion (Actual)

February 20, 2012

Study Registration Dates

First Submitted

May 5, 2010

First Submitted That Met QC Criteria

May 6, 2010

First Posted (Estimate)

May 7, 2010

Study Record Updates

Last Update Posted (Actual)

February 8, 2019

Last Update Submitted That Met QC Criteria

February 6, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J0868
  • R01CA161265-02 (U.S. NIH Grant/Contract)
  • NA_00016040 (Other Identifier: JHM IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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