Multimodal Spectroscopy (MMS) for in Vivo Noninvasive Assessment of Skin

NCT02704039 | Completed

• 1 other identifier: 2013-07-0008
• Study Type: observational
• Target: 239
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research program is to develop a simple, noninvasive diagnostic device for assessing skin pathology without the need for a biopsy. The device being studied is a single system capable of collecting three spectroscopy measurements (Raman, diffuse reflectance and laser induced fluorescence spectroscopy) from skin lesion sites. In order to accomplish this objective, the investigators propose to: 1) develop biophysical model for Raman spectroscopy of skin cancers, 2) conduct a clinical pilot study to collect MMS data from a minimum of 250 patients to determine the diagnostic accuracy (sensitivity and specificity) of MMS for diagnosing skin malignancy.

Conditions

Skin Cancer

Outcome Measures

Primary Outcomes (2)

• Aim 1: Develop biophysical model for Raman spectroscopy

  use of a new technique of biophysical modeling to analyze the Raman spectra. At the core of the technique is the measurement of a set of "basis spectra" which are fit to the data using ordinary least-squares.

  6 months

• Aim 2: Perform clinical assessment of MMS for skin malignancy

  develop a biophysically-orientated model of human skin using Raman spectroscopy, with the goal of obtaining tissue microenvironment structural and chemical information.

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Health adult volunteers being evaluated by dermatologist for lesion of interest (see inclusion criteria).

You may qualify if:

• Patients undergoing examination of skin
• Male or Female 18 years and older
• Patients with lesion(s) including one of the following: BCC, SCC, pre-cancerous, pigmented lesion, benign lesions, OR suspected diagnosis of psoriasis, eczema, dermatitis, lichen planus and/or lupus.
• Signed consent form

You may not qualify if:

• Patients with skin lesions in difficult to measure locations
• Patients that do not sign the consent forms

Sponsors & Collaborators

• University of Texas at Austin: lead
• Seton Healthcare Family: collaborator
• Cancer Prevention Research Institute of Texas: collaborator

Study Sites (1)

Seton Dermatology Clinics

Austin, Texas, 78701, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• James Tunnell, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

• Jason Reichenberg, MD

  Seton & The University of Texas at Austin Dell Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 9, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)