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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05554523
Other study ID # IRAS307166
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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