How Does Skin Tone Affect Quantitative Photoacoustic Imaging

Vitiligo Clinical Trial

— PAISKINTONE  

Official title:

How Does Skin Tone Affect Quantitative Photoacoustic Imaging

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05554523
• Other study ID #: IRAS307166
• Status: Not yet recruiting
• Start date: October 1, 2022
• Est. completion date: October 15, 2023

Study information

• Verified date: September 2022
• Source: University of Cambridge
• Contact: Sarah Bohndiek
• Phone: +44 (0) 1223 337267
• Email: seb53[@]cam.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: October 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Skin Abnormalities
• Vitiligo

Intervention

Device:
• Photoacoustic imaging
Photoacoustic imaging

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Cambridge	Cancer Research UK

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative photoacoustic imaging	Identify biases in quantitative photoacoustic imaging when scanning people with different Fitzpatrick skin tones and Vitiligo.	1 year