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Clinical Trials/NCT02154451
NCT02154451UnknownPhase 1

Transient Infrared Imaging for Early Detection of Skin Cancer

Skinfrared LLC5 sites in 1 country400 target enrollmentStarted: August 1, 2013Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Sponsor
Enrollment
400
Locations
5
Primary Endpoint
To detect skin cancers with >90% sensitivity and >50% specificity using infrared imaging

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Screening
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All lesion in easily accessible places
  • Lesion less than 3.5 cm

Exclusion Criteria

  • Any minors
  • Lesion close to vital organs

Outcomes

Primary Outcomes

To detect skin cancers with >90% sensitivity and >50% specificity using infrared imaging

Time Frame: 5 years

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,

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Skinfrared LLC
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (5)

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