Award Abstract # 2326485
NSF/FDA SiR: Validation and Standardization of Melanometry as a Quantitative Tool for Clinical Evaluation of Racial Disparities in Biophotonic Devices

NSF Org: CBET
Division of Chemical, Bioengineering, Environmental, and Transport Systems
Recipient: UNIVERSITY OF CALIFORNIA IRVINE
Initial Amendment Date: August 7, 2023
Latest Amendment Date: August 7, 2023
Award Number: 2326485
Award Instrument: Standard Grant
Program Manager: Steve Zehnder
szehnder@nsf.gov
 (703)292-7014
CBET
 Division of Chemical, Bioengineering, Environmental, and Transport Systems
ENG
 Directorate for Engineering
Start Date: October 1, 2023
End Date: May 31, 2024 (Estimated)
Total Intended Award Amount: $200,000.00
Total Awarded Amount to Date: $200,000.00
Funds Obligated to Date: FY 2023 = $0.00
History of Investigator:
  • Robert Wilson (Principal Investigator)
    rwilson3@udayton.edu
Recipient Sponsored Research Office: University of California-Irvine
160 ALDRICH HALL
IRVINE
CA  US  92697-0001
(949)824-7295
Sponsor Congressional District: 47
Primary Place of Performance: Beckman Laser Institute
1002 Health Sciences Road
Irvine
CA  US  92617-3010
Primary Place of Performance
Congressional District:
47
Unique Entity Identifier (UEI): MJC5FCYQTPE6
Parent UEI: MJC5FCYQTPE6
NSF Program(s): Special Initiatives,
BioP-Biophotonics
Primary Program Source: 01002324DB NSF RESEARCH & RELATED ACTIVIT
Program Reference Code(s):
Program Element Code(s): 164200, 723600
Award Agency Code: 4900
Fund Agency Code: 4900
Assistance Listing Number(s): 47.041

ABSTRACT

Recent studies have shown that medical devices can be less accurate for patients with darker versus lighter skin. This problem can negatively affect the ability of doctors to make correct decisions about how to treat these patients, leading to worse health outcomes for patients with darker skin. Most experts believe that the primary cause of this effect is the absorption of light by melanin in the top layer of the skin. There are wide variations in the amount of melanin in the skin among the population. Instruments called melanometers can measure variables related to the amount of melanin in the skin. Using data from melanometers may help to properly account for the effect of melanin on the accuracy of medical devices in diverse populations. This proposal will develop materials that mimic skin with different amounts of melanin and blood and measure these materials with melanometers to better understand the effects of melanin and blood on the data obtained with melanometers. This project may lead to improved methods for making sure that medical devices are safe and effective for patients of all races and skin types. Results of this project will be incorporated into courses at the University of California Irvine on identifying disparities in health outcomes to illustrate how technologies can be developed and validated in a way that is equally accurate across diverse groups of patients.

Ensuring robustness of biophotonic technologies across the full range of skin colors is crucial for healthcare equity in clinical environments and personal health monitoring settings. Over the past two decades, numerous studies have identified racial disparities in biophotonic devices, from cerebral oximeters to photoacoustic imagers. These discrepancies can adversely impact clinical decision making, leading to worse health outcomes for patients with darker skin. Most experts believe that the primary cause of this effect is the intense, spectrally varying absorption of epidermal melanin; the concentration of which varies considerably across the population. To determine the magnitude of impact on a device, one must accurately determine the correlation between melanin content and device outputs/accuracy. Prior studies have used subjective methods, including self-identification of race and the Fitzpatrick phototype scale to assess subject pigmentation. However, objective, quantitative, and well-standardized methods based on optical measurements may provide a more precise and effective way to isolate the impact of epidermal melanin. The PI and collaborators will pursue this goal via constructing a rigorous set of synthetic tissue-simulating phantoms and using these phantoms as calibration standards to systematically characterize commercial (non-FDA-approved/cleared) melanometers for measuring skin pigmentation. Validating the outputs of these commercial devices against a well-characterized set of tissue models that simulate both melanin content and confounding tissue factors (e.g., hemoglobin, tissue scattering) will provide a critical fundamental step forward in establishing the credibility of melanometers as regulatory science tools.

This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

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