How Does Skin Tone Affect Quantitative Photoacoustic Imaging

Not yet recruiting

• Conditions: Vitiligo; Skin Abnormalities
• Interventions: Device: Photoacoustic imaging

• Registration Number: NCT05554523
• Lead Sponsor: University of Cambridge

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-23
• Last Update Submitted: 2022-09-23
• Study First Posted: 2022-09-26
• Last Update Posted: 2022-09-26
• Study Start: 2022-10-01
• Primary Completion: 2023-04-15
• Study Completion: 2023-10-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fitzpatrick Type 3	Photoacoustic imaging	-
Fitzpatrick Type 2	Photoacoustic imaging	-
Fitzpatrick Type 5	Photoacoustic imaging	-
Fitzpatrick Type 6	Photoacoustic imaging	-
Fitzpatrick Type 1	Photoacoustic imaging	-
Vitiligo	Photoacoustic imaging	-
Fitzpatrick Type 4	Photoacoustic imaging	-

Primary Outcome Measures

Name	Time	Method
Quantitative photoacoustic imaging	1 year	Identify biases in quantitative photoacoustic imaging when scanning people with different Fitzpatrick skin tones and Vitiligo.