Back to resultsTransient Infrared Imaging for Early Detection of Skin Cancer
Primary Purpose
Skin Cancer
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Infrared Imaging Device- ALIAS
Sponsored by
About this trial
This is an interventional screening trial for Skin Cancer
Eligibility Criteria
Inclusion Criteria:
- All lesion in easily accessible places
- Lesion less than 3.5 cm
Exclusion Criteria:
- Any minors
- Lesion close to vital organs
Sites / Locations
- University of New Mexico, Derm ClinicRecruiting
- Univesity of New Mexico, Derm ClinicRecruiting
- University of new Mexico, Dermatology clinicRecruiting
Outcomes
Primary Outcome Measures
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,
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02154451
Brief Title
Transient Infrared Imaging for Early Detection of Skin Cancer
Official Title
Transient Infrared Imaging for Early Detection of Skin Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Skinfrared LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Infrared Imaging Device- ALIAS
Intervention Description
Infrared Camera
Primary Outcome Measure Information:
Title
To detect skin cancers with >90% sensitivity and >50% specificity using infrared imaging
Description
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,
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
All lesion in easily accessible places
Lesion less than 3.5 cm
Exclusion Criteria:
Any minors
Lesion close to vital organs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sanchita Krishna, PhD
Phone
505 453 3349
Email
sanchita@skinfrared.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanchita krishna, PhD
Organizational Affiliation
Skinfrared LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico, Derm Clinic
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanchita Krishna, PhD
Phone
505-453-3349
Email
sanchita@skinfrared.com
First Name & Middle Initial & Last Name & Degree
Steve Padilla, MD
Facility Name
Univesity of New Mexico, Derm Clinic
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanchita Krishna, PhD
Phone
505-453-3349
Email
sanchita@skinfrared.com
Facility Name
University of new Mexico, Dermatology clinic
City
Albuquerque
State/Province
New Mexico
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanchita Krishna, PhD
Phone
505-453-3349
Email
sanchita@skinfrared.com
12. IPD Sharing Statement
Learn more about this trial
Transient Infrared Imaging for Early Detection of Skin Cancer
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