NCT02154451

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

June 3, 2014

Status Verified

May 1, 2014

Enrollment Period

1.3 years

First QC Date

May 20, 2014

Last Update Submit

May 30, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Infrared Camera

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Any minors
  • Lesion close to vital organs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of New Mexico, Derm Clinic

Albuquerque, New Mexico, 87131, United States

RECRUITING

Univesity of New Mexico, Derm Clinic

Albuquerque, New Mexico, 87131, United States

RECRUITING

University of new Mexico, Dermatology clinic

Albuquerque, New Mexico, United States

RECRUITING

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sanchita krishna, PhD

    Skinfrared LLC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanchita Krishna, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2014

First Posted

June 3, 2014

Study Start

August 1, 2013

Primary Completion

December 1, 2014

Last Updated

June 3, 2014

Record last verified: 2014-05

Locations