ClinicalTrials.gg
Status unknownNCT05554523PAISKINTONEUpdated Sep 26, 2022

How Does Skin Tone Affect Quantitative Photoacoustic Imaging

An observational study in Vitiligo and Skin Abnormalities, sponsored by University of Cambridge. Status unknown. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-26.

Sponsored by University of Cambridge · Observational

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
42
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Vitiligo
  • Skin Abnormalities
03

In context

Vitiligo

343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.

This study's planned enrollment of 42 is below the median of 114 across 67 observational studies indexed under Vitiligo.

Browse Vitiligo studies →

Lead sponsor

University of Cambridge is the lead sponsor of 116 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Normal adult population across range of skin tones

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. No participants who cannot give .
  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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
42 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DevicePhotoacoustic imaging

    Photoacoustic imaging

06

What researchers measure

Primary outcomes

  1. Quantitative photoacoustic imaging

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

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05554523
Collaborators
Cancer Research UK
Responsible party
Sarah Bohndiek (Professor, University of Cambridge) — Principal investigator
First posted
Sep 26, 2022
Start date
Oct 1, 2022 (estimated)
Primary completion
Apr 15, 2023 (estimated)
Completion
Oct 15, 2023 (estimated)
Last update
Sep 26, 2022

Study contacts

Sarah Bohndiek
Contact
seb53@cam.ac.uk
+44 (0) 1223 337267

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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