How Does Skin Tone Affect Quantitative Photoacoustic Imaging

NCT ID: NCT05554523

Last Updated: 2022-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-10-15

Brief Summary

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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

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Conditions

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Vitiligo Skin Abnormalities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Vitiligo

Photoacoustic imaging

Intervention Type DEVICE

Photoacoustic imaging

Fitzpatrick Type 1

Photoacoustic imaging

Intervention Type DEVICE

Photoacoustic imaging

Fitzpatrick Type 2

Photoacoustic imaging

Intervention Type DEVICE

Photoacoustic imaging

Fitzpatrick Type 3

Photoacoustic imaging

Intervention Type DEVICE

Photoacoustic imaging

Fitzpatrick Type 4

Photoacoustic imaging

Intervention Type DEVICE

Photoacoustic imaging

Fitzpatrick Type 5

Photoacoustic imaging

Intervention Type DEVICE

Photoacoustic imaging

Fitzpatrick Type 6

Photoacoustic imaging

Intervention Type DEVICE

Photoacoustic imaging

Interventions

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Photoacoustic imaging

Photoacoustic imaging

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cancer Research UK

OTHER

Sponsor Role collaborator

University of Cambridge

OTHER

Sponsor Role lead

Responsible Party

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Sarah Bohndiek

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Sarah Bohndiek

Role: CONTACT

+44 (0) 1223 337267

Other Identifiers

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IRAS307166

Identifier Type: -

Identifier Source: org_study_id

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