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NCT02154451 Clinical Trial

Transient Infrared Imaging for Early Detection of Skin Cancer

Skin Cancer Clinical Trial

Official title:
Transient Infrared Imaging for Early Detection of Skin Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02154451
Other study ID # 10-304
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received May 20, 2014
Last updated May 30, 2014
Start date August 2013

Study information
Verified date May 2014
Source Skinfrared LLC
Contact Sanchita Krishna, PhD
Phone 505 453 3349
Email sanchita@skinfrared.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The hypothesis or study goal is to determine whether functional dynamic infrared imaging can be used for melanoma and other skin cancer screening and/or diagnosis.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All lesion in easily accessible places

- Lesion less than 3.5 cm

Exclusion Criteria:

- Any minors

- Lesion close to vital organs

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Device:
• Infrared Imaging Device- ALIAS
Infrared Camera

Locations
Country Name City State
United States University of New Mexico, Derm Clinic Albuquerque New Mexico
United States University of new Mexico, Dermatology clinic Albuquerque New Mexico
United States Univesity of New Mexico, Derm Clinic Albuquerque New Mexico

Sponsors (1)
Lead Sponsor Collaborator
Skinfrared LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To detect skin cancers with >90% sensitivity and >50% specificity using infrared imaging We are developing a screening algorithm than can compute data from infrared pictures and give us a threshold below which all the cases are benign and above which is malignant.
Our primary outcome is to detect all the malignant cases with more than 90% sensitivity and all the benign cases with more than 50% specificity,		 5 years Yes
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