How Does Skin Tone Affect Quantitative Photoacoustic Imaging

NCT05554523 | Unknown

• 1 other identifier: IRAS307166
• Study Type: observational
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vitiligo; Skin Abnormalities

Outcome Measures

Primary Outcomes (1)

• Quantitative photoacoustic imaging

  Identify biases in quantitative photoacoustic imaging when scanning people with different Fitzpatrick skin tones and Vitiligo.

  1 year

Study Arms (7)

Vitiligo

Device: Photoacoustic imaging

Fitzpatrick Type 1

Device: Photoacoustic imaging

Fitzpatrick Type 2

Device: Photoacoustic imaging

Fitzpatrick Type 3

Device: Photoacoustic imaging

Fitzpatrick Type 4

Device: Photoacoustic imaging

Fitzpatrick Type 5

Device: Photoacoustic imaging

Fitzpatrick Type 6

Device: Photoacoustic imaging

Interventions

Photoacoustic imaging DEVICE

Photoacoustic imaging

Fitzpatrick Type 1; Fitzpatrick Type 2; Fitzpatrick Type 3; Fitzpatrick Type 4; Fitzpatrick Type 5; Fitzpatrick Type 6; Vitiligo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normal adult population across range of skin tones

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cambridge: lead
• Cancer Research UK: collaborator

MeSH Terms

Conditions

Vitiligo; Skin Abnormalities

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Sarah Bohndiek

CONTACT

+44 (0) 1223 337267; seb53@cam.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 26, 2022
• Study Start: October 1, 2022
• Primary Completion: April 15, 2023
• Study Completion: October 15, 2023
• Last Updated: September 26, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share