How Does Skin Tone Affect Quantitative Photoacoustic Imaging (PAISKINTONE)

Photoacoustic imaging (PAI) is an emerging method which combines light and ultrasound to assess the blood content and oxygenation of the body. Light is absorbed by the blood, leading to the generation of ultrasound, from which the levels of oxygen can be derived. This high sensitivity to blood has seen it applied in multiple clinical trials for the assessment of a number of conditions including breast cancer assessment. However, the accuracy of the measurements and image quality is known to decrease as you look deeper into the body because light intensity decreases. Melanin in the skin is known to absorb light very strongly and so there is considerable concern that this may bias measurements made in people with darker skin tones compared to those with lighter skin tones. In this pilot study, we intend to recruit volunteers with a wide range of skin tones and vitiligo. We will scan a number of blood vessels and muscles using PAI and evaluate the photoacoustic measurements of blood content and oxygenation to identify, and ultimately correct for, biases in advance of further clinical studies.

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Abnormalities; Vitiligo
• Intervention / Treatment: Device: Photoacoustic imaging

• Study Type: Observational
• Enrollment (Anticipated): 42

Contacts and Locations

• Study Contact: Name: Sarah Bohndiek; Phone Number: +44 (0) 1223 337267; Email: seb53@cam.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Normal adult population across range of skin tones

Description

Inclusion Criteria:

1. Voluntary adult non-vulnerable participants between the age of 20 to 70.
2. Can understand the Information sheet and give informed consent in English.
3. Normal or Overweight BMI (18.5 to 29.9)

Exclusion Criteria:

1. No participants who cannot give informed consent.
2. No tattoos or scarring of the regions to be imaged.
3. No pulmonary sleep disorder, or active respiratory disorders that may affect the blood oxygenation levels.

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vitiligo	Device: Photoacoustic imaging; Photoacoustic imaging
Fitzpatrick Type 1	Device: Photoacoustic imaging; Photoacoustic imaging
Fitzpatrick Type 2	Device: Photoacoustic imaging; Photoacoustic imaging
Fitzpatrick Type 3	Device: Photoacoustic imaging; Photoacoustic imaging
Fitzpatrick Type 4	Device: Photoacoustic imaging; Photoacoustic imaging
Fitzpatrick Type 5	Device: Photoacoustic imaging; Photoacoustic imaging
Fitzpatrick Type 6	Device: Photoacoustic imaging; Photoacoustic imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative photoacoustic imaging	Identify biases in quantitative photoacoustic imaging when scanning people with different Fitzpatrick skin tones and Vitiligo.	1 year

Collaborators and Investigators

• Sponsor: University of Cambridge
• Collaborators: Cancer Research UK

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): April 15, 2023
• Study Completion (Anticipated): October 15, 2023

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Congenital Abnormalities; Pigmentation Disorders; Hypopigmentation; Vitiligo; Skin Abnormalities
• Other Study ID Numbers: IRAS307166

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No