Trial record 3 of 21 for:    ALIAS

Transient Infrared Imaging for Early Detection of Skin Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Skinfrared LLC
Sponsor:
Information provided by (Responsible Party):
Skinfrared LLC
ClinicalTrials.gov Identifier:
NCT02154451
First received: May 20, 2014
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Skin Cancer
Device: Infrared Imaging Device- ALIAS
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Screening
Official Title: Transient Infrared Imaging for Early Detection of Skin Cancer

Resource links provided by NLM:


Further study details as provided by Skinfrared LLC:

Primary Outcome Measures:
  • To detect skin cancers with >90% sensitivity and >50% specificity using infrared imaging [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    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,



Estimated Enrollment: 400
Study Start Date: August 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Infrared Imaging Device- ALIAS
    Infrared Camera
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Any minors
  • Lesion close to vital organs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02154451

Contacts
Contact: Sanchita Krishna, PhD 505 453 3349 sanchita@skinfrared.com

Locations
United States, New Mexico
University of new Mexico, Dermatology clinic Recruiting
Albuquerque, New Mexico, United States
Contact: Sanchita Krishna, PhD    505-453-3349    sanchita@skinfrared.com   
Univesity of New Mexico, Derm Clinic Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Sanchita Krishna, PhD    505-453-3349    sanchita@skinfrared.com   
University of New Mexico, Derm Clinic Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Sanchita Krishna, PhD    505-453-3349    sanchita@skinfrared.com   
Principal Investigator: Steve Padilla, MD         
Sponsors and Collaborators
Skinfrared LLC
Investigators
Principal Investigator: Sanchita krishna, PhD Skinfrared LLC
  More Information

No publications provided

Responsible Party: Skinfrared LLC
ClinicalTrials.gov Identifier: NCT02154451     History of Changes
Other Study ID Numbers: 10-304
Study First Received: May 20, 2014
Last Updated: May 30, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014