VitiligoPAISKINTONENCT05554523
How Does Skin Tone Affect Quantitative Photoacoustic Imaging
An observational study of Vitiligo and Skin Abnormalities, run by University of Cambridge.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitiligo, Skin Abnormalities
- What is being tested?
- Photoacoustic imaging
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 15 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal adult population across range of skin tones
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Photoacoustic imaging
- Medical subject headings
- Vitiligo, Skin Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photoacoustic imagingDevice
Photoacoustic imaging
| Study group | Role | What they receive |
|---|---|---|
| Vitiligo | Not described Receives: Device: Photoacoustic imaging | |
| Fitzpatrick Type 1 | Not described Receives: Device: Photoacoustic imaging | |
| Fitzpatrick Type 2 | Not described Receives: Device: Photoacoustic imaging | |
| Fitzpatrick Type 3 | Not described Receives: Device: Photoacoustic imaging | |
| Fitzpatrick Type 4 | Not described Receives: Device: Photoacoustic imaging | |
| Fitzpatrick Type 5 | Not described Receives: Device: Photoacoustic imaging | |
| Fitzpatrick Type 6 | Not described Receives: Device: Photoacoustic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative photoacoustic imaging
Identify biases in quantitative photoacoustic imaging when scanning people with different Fitzpatrick skin tones and Vitiligo.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion15 Apr 2023 (estimated)
- Study completion15 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK
- Responsible party
- Principal investigator, Sarah Bohndiek, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554523
- Sponsor's protocol ID
- IRAS307166
- Acronym
- PAISKINTONE
- Status last verified
- Sep 2022
- First submitted
- 21 Sep 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Skin Tone Affect Quantitative Photoacoustic Imaging
- ClinicalTrials.gov ID
- NCT05554523
- Acronym / sponsor ID
- PAISKINTONE / IRAS307166
- Conditions
- Vitiligo, Skin Abnormalities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cancer Research UK
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal adult population across range of skin tones
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photoacoustic imagingPhotoacoustic imaging | Device | Fitzpatrick Type 1, Fitzpatrick Type 2, Fitzpatrick Type 3, Fitzpatrick Type 4, Fitzpatrick Type 5, Fitzpatrick Type 6, Vitiligo |
Primary outcome
Quantitative photoacoustic imaging
Time frame: 1 year
Identify biases in quantitative photoacoustic imaging when scanning people with different Fitzpatrick skin tones and Vitiligo.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitiligo and Skin Abnormalities, run by University of Cambridge.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Bohndiek (+44 (0) 1223 337267, seb53@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative photoacoustic imaging (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.