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NCT01118832 Clinical Trial

Using High Resolution Function Imaging To Detect Melanoma and Dysplastic Nevi

Melanoma Clinical Trial

Official title:
Using High Resolution Function Imaging To Detect Melanoma and Dysplastic Nevi

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01118832
Other study ID # J0868
Secondary ID R01CA161265-02NA
Status Completed
Phase
First received
Last updated
Start date September 22, 2009
Est. completion date February 20, 2012

Study information
Verified date February 2019
Source Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date February 20, 2012
Est. primary completion date June 29, 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 80 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Johns Hopkins Medicine Baltimore Maryland

Sponsors (3)
Lead Sponsor Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Johns Hopkins University, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

C HERMAN, THREE-DIMENSIONAL THERMAL IMAGING FOR THE DETECTION OF SKIN LESIONS AND OTHER NATURAL AND ABNORMAL CONDITIONS - WO Patent WO/2012/009,359, 2012

Herman C. Emerging technologies for the detection of melanoma: achieving better outcomes. Clin Cosmet Investig Dermatol. 2012;5:195-212. doi: 10.2147/CCID.S27902. Epub 2012 Nov 12. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Ability to Detect of the melanoma lesions 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 Measurement of thermal signatures of benign cutaneous lesions up to 2 years
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