HealthyNCT06541496
Influence of Fitzpatrick Skin Phototype and Body Mass Index on Non-invasive Optoacoustic Imaging
An observational study of Healthy, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Multispectral Optoacoustic Tomography (MSOT) is a promising imaging technology that utilizes pulsed laser light. While melanin content in the skin has been reported to influence light-based measurements in pulse oximetry and near-infrared spectroscopy, its effects on MSOT are not well understood. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Multispectral Optoacoustic Tomography (MSOT)
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jun 2024to 31 Dec 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eligible subjects are healthy volunteers who will be recruited from advertised announcements. All subjects meeting all inclusion and none of the exclusion criteria will be enrolled. Each healthy volunteer is categorized in 2 different groups based on his FSP and BMI: 1. FSP I, II, III, IV, V or VI, using the filled Fitzpatrick scale self-assessment questionnaire. 2. BMI<18.5 kg/m2, ≥ 18.5 and < 25 kg/m2 or ≥ 25 kg/m2, using the measured body weight and recorded body height.
Who may be able to join
- Signed informed consent
Who cannot join
- Pregnancy
- diagnosed diabetes
- diagnosed renal insufficiency
- diagnosed Peripheral arterial disease
- diagnosed muscle associated disease
- tattoos in scan area
- missing consent form
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
iThera Medical Headquarters
Munich, Bavaria, 81379
Charlene Reichl
About this study
Official title: Influence of Fitzpatrick Skin Phototype and Body Mass Index on Non-invasive Optoacoustic Imaging of Muscle During Vascular Restriction and Physical Activity
Multispectral Optoacoustic Tomography (MSOT) is a promising imaging technology that utilizes pulsed laser light. While melanin content in the skin has been reported to influence light-based measurements in pulse oximetry and near-infrared spectroscopy, its effects on MSOT are not well understood. This proposed study aims to investigate how different Fitzpatrick skin phenotypes (FSP) and body mass index (BMI) influence muscle perfusion and oxygenation during arterial occlusion and muscle exercise over time. Healthy volunteers with varying skin tones (as defined by FSP) and BMI will be recruited and subjected to leg arterial occlusion and toe raise exercises. They will then be scanned on different body areas (arms and legs) to assess changes in muscle perfusion and oxygenation using MSOT.
Read the detailed description
Melanin, a pigment found in the skin, has been reported to influence light-based measurements such as pulse oximetry or near-infrared spectroscopy (NIRS). Studies have shown measurements overestimation of darker skin tones or in ethnicities assumed to have darker skin tones compared to lighter skin tones. Even though optoacoustic imaging (OAI) has a different depth penetration than NIRS or pulse oximetry, the technology uses pulse laser light to assess tissue.
Multispectral Optoacoustic Tomography (MSOT) imaging is similar to conventional sonography: a transducer is placed on the skin, and instead of sound, energy is applied to the tissue by means of pulsed laser light. This leads to a constant change of minimal expansion and contraction of individual tissue components or molecules. The resulting sound waves can then be detected by the same device. Previous studies have already shown that the quantitative determination of hemoglobin can provide information on inflammatory activities or muscle hemodynamics. MSOT uses laser light between 660 and 1300nm to visualize and quantify different endogenous chromophores, such as hemoglobin, collagen, or melanin. Increase in melanin concentration (e.g. in melanomas or skin tags) has been previously assessed using the technology but never looked at signal at depth. Additionally, differences in body-mass-index (BMI) might influence light penetration, and therefore, the optoacoustic signal at depth. So far, no studies have looked at the influence of increased melanin concentration or subcutaneous fat on quantification of muscle perfusion and oxygenation.
In this first pilot study, the aim is to investigate the influence of different Fitzpatrick skin phenotypes (FSP) and BMI on muscle perfusion and oxygenation during arterial occlusion or muscle exercise and over time. This information is essential for further studies with a more diverse study population.
To gain insights into these differences, healthy volunteers with different skin tone (defined by FSP) and body-mass-index will be recruited and subjected to a leg arterial occlusion and to perform a toe raise exercise. They will then be scanned on different body areas (arm, legs) to assess changes in muscle perfusion and oxygenation by MSOT.
- Conditions
- Healthy
- Being tested
- Multispectral Optoacoustic Tomography (MSOT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispectral Optoacoustic Tomography (MSOT)Device
Non-invasive transcutaneous MSOT imaging of muscle regions.
| Study group | Role | What they receive |
|---|---|---|
| Fitzpatrick 1 | Healthy volunteers with skin type 1. Receives: Device: Multispectral Optoacoustic Tomography (MSOT) | |
| Fitzpatrick 2 | Healthy volunteers with skin type 2. Receives: Device: Multispectral Optoacoustic Tomography (MSOT) | |
| Fitzpatrick 3 | Healthy volunteers with skin type 3. Receives: Device: Multispectral Optoacoustic Tomography (MSOT) | |
| Fitzpatrick 4 | Healthy volunteers with skin type 4. Receives: Device: Multispectral Optoacoustic Tomography (MSOT) | |
| Fitzpatrick 5 | Healthy volunteers with skin type 5. Receives: Device: Multispectral Optoacoustic Tomography (MSOT) | |
| Fitzpatrick 6 | Healthy volunteers with skin type 6. Receives: Device: Multispectral Optoacoustic Tomography (MSOT) | |
| BMI Group 1 | Healthy volunteers with BMI <18.5. Receives: Device: Multispectral Optoacoustic Tomography (MSOT) | |
| BMI Group 2 | Healthy volunteers with BMI >18.5 but <25. Receives: Device: Multispectral Optoacoustic Tomography (MSOT) | |
| BMI Group 3 | Healthy volunteers with BMI >25. Receives: Device: Multispectral Optoacoustic Tomography (MSOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative hemoglobin-associated signal (in arbitrary units)
Hemoglobin signal in the measured muscle regions in all different cohorts
Measured: immediately before and after intervention (occlusion and exercise)
Secondary outcomes (14)
Muscle oxygenation (in arbitrary units)
Oxygenated hemoglobin signal in the measured muscle regions in all different cohorts
Measured: immediately before and after intervention (occlusion and exercise)
Oxygen saturation (in %)
Proportion of oxygenated hemoglobin signal compared with total hemoglobin signal in the measured muscle regions in all different cohorts
Measured: immediately before and after intervention (occlusion and exercise)
Heart rate (in bpm)
heart rate of the healthy volunteers
Measured: immediately before and after intervention (occlusion and exercise)
Blood pressure (in mm Hg)
blood pressure of the healthy volunteers
Measured: immediately before and after intervention (occlusion and exercise)
Weight (in kg)
measured by body scale
Measured: baseline
Age in years
Participant questionnaire.
Measured: baseline
Gender: male, female, other
Participant questionnaire.
Measured: baseline
Skin tone based on Fitzpatrick questionnaire self-assessment (type 1-6, 1 being the palest, 6 being the darkest)
Participant questionnaire.
Measured: baseline
Dominant side
Participant questionnaire.
Measured: baseline
Sport frequency
Participant questionnaire.
Measured: baseline
Information on last physical exercise and caffeine and alcohol consumption
Participant questionnaire.
Measured: baseline
Quantitative collagen, lipid, water and melanin signal (in arbitrary units)
Signal in the measured muscle regions and the skin (melanin) in all different cohorts
Measured: immediately before and after intervention (occlusion and exercise)
Skin tone based on Fitzpatrick scale self-assessment (type 1-6, 1 being the palest, 6 being the darkest)
color card as reference
Measured: baseline
Skin tone based on Fitzpatrick scale examiner-assessment (type 1-6, 1 being the palest, 6 being the darkest)
color card as reference
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start14 Jun 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ferdinand Knieling, PD Dr. med. habil., Principal investigator, Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541496
- Sponsor's protocol ID
- cMSOT2-HV-01
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Raw data will be transferred to iThera Medical GmbH in anonymized form. iThera Medical GmbH is authorized to further transfer the anonymized data to the American Food and Drug Administration. The study results will be published anonymously in a scientific journal. Additionally, the raw data is planned to be published by the Friedrich-Alexander-University in an open-source manner to serve as reference standard. However it will not be possible to draw conclusions about the identity of the participating individuals.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Fitzpatrick Skin Phototype and Body Mass Index on Non-invasive Optoacoustic Imaging of Muscle During Vascular Restriction and Physical Activity
- ClinicalTrials.gov ID
- NCT06541496
- Acronym / sponsor ID
- cMSOT2-HV-01
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Aug 2024 (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.
Multispectral Optoacoustic Tomography (MSOT) is a promising imaging technology that utilizes pulsed laser light. While melanin content in the skin has been reported to influence light-based measurements in pulse oximetry and near-infrared spectroscopy, its effects on MSOT are not well understood. This proposed study aims to investigate how different Fitzpatrick skin phenotypes (FSP) and body mass index (BMI) influence muscle perfusion and oxygenation during arterial occlusion and muscle exercise over time. Healthy volunteers with varying skin tones (as defined by FSP) and BMI will be recruited and subjected to leg arterial occlusion and toe raise exercises. They will then be scanned on different body areas (arms and legs) to assess changes in muscle perfusion and oxygenation using MSOT.
Detailed description
Melanin, a pigment found in the skin, has been reported to influence light-based measurements such as pulse oximetry or near-infrared spectroscopy (NIRS). Studies have shown measurements overestimation of darker skin tones or in ethnicities assumed to have darker skin tones compared to lighter skin tones. Even though optoacoustic imaging (OAI) has a different depth penetration than NIRS or pulse oximetry, the technology uses pulse laser light to assess tissue.
Multispectral Optoacoustic Tomography (MSOT) imaging is similar to conventional sonography: a transducer is placed on the skin, and instead of sound, energy is applied to the tissue by means of pulsed laser light. This leads to a constant change of minimal expansion and contraction of individual tissue components or molecules. The resulting sound waves can then be detected by the same device. Previous studies have already shown that the quantitative determination of hemoglobin can provide information on inflammatory activities or muscle hemodynamics. MSOT uses laser light between 660 and 1300nm to visualize and quantify different endogenous chromophores, such as hemoglobin, collagen, or melanin. Increase in melanin concentration (e.g. in melanomas or skin tags) has been previously assessed using the technology but never looked at signal at depth. Additionally, differences in body-mass-index (BMI) might influence light penetration, and therefore, the optoacoustic signal at depth. So far, no studies have looked at the influence of increased melanin concentration or subcutaneous fat on quantification of muscle perfusion and oxygenation.
In this first pilot study, the aim is to investigate the influence of different Fitzpatrick skin phenotypes (FSP) and BMI on muscle perfusion and oxygenation during arterial occlusion or muscle exercise and over time. This information is essential for further studies with a more diverse study population.
To gain insights into these differences, healthy volunteers with different skin tone (defined by FSP) and body-mass-index will be recruited and subjected to a leg arterial occlusion and to perform a toe raise exercise. They will then be scanned on different body areas (arm, legs) to assess changes in muscle perfusion and oxygenation by MSOT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Fitzpatrick 1 | – | Device: Multispectral Optoacoustic Tomography (MSOT)Healthy volunteers with skin type 1. |
| Fitzpatrick 2 | – | Device: Multispectral Optoacoustic Tomography (MSOT)Healthy volunteers with skin type 2. |
| Fitzpatrick 3 | – | Device: Multispectral Optoacoustic Tomography (MSOT)Healthy volunteers with skin type 3. |
| Fitzpatrick 4 | – | Device: Multispectral Optoacoustic Tomography (MSOT)Healthy volunteers with skin type 4. |
| Fitzpatrick 5 | – | Device: Multispectral Optoacoustic Tomography (MSOT)Healthy volunteers with skin type 5. |
| Fitzpatrick 6 | – | Device: Multispectral Optoacoustic Tomography (MSOT)Healthy volunteers with skin type 6. |
| BMI Group 1 | – | Device: Multispectral Optoacoustic Tomography (MSOT)Healthy volunteers with BMI <18.5. |
| BMI Group 2 | – | Device: Multispectral Optoacoustic Tomography (MSOT)Healthy volunteers with BMI >18.5 but <25. |
| BMI Group 3 | – | Device: Multispectral Optoacoustic Tomography (MSOT)Healthy volunteers with BMI >25. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible subjects are healthy volunteers who will be recruited from advertised announcements. All subjects meeting all inclusion and none of the exclusion criteria will be enrolled. Each healthy volunteer is categorized in 2 different groups based on his FSP and BMI: 1. FSP I, II, III, IV, V or VI, using the filled Fitzpatrick scale self-assessment questionnaire. 2. BMI<18.5 kg/m2, ≥ 18.5 and < 25 kg/m2 or ≥ 25 kg/m2, using the measured body weight and recorded body height.
Key inclusion criteria (1 listed)
- Signed informed consent
Key exclusion criteria (7 listed)
- Pregnancy
- diagnosed diabetes
- diagnosed renal insufficiency
- diagnosed Peripheral arterial disease
- diagnosed muscle associated disease
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 |
|---|---|---|
| Multispectral Optoacoustic Tomography (MSOT)Non-invasive transcutaneous MSOT imaging of muscle regions. | Device | BMI Group 1, BMI Group 2, BMI Group 3, Fitzpatrick 1, Fitzpatrick 2, Fitzpatrick 3, Fitzpatrick 4, Fitzpatrick 5, Fitzpatrick 6 |
Primary outcome
Quantitative hemoglobin-associated signal (in arbitrary units)
Time frame: immediately before and after intervention (occlusion and exercise)
Hemoglobin signal in the measured muscle regions in all different cohorts
14 secondary outcomes
Muscle oxygenation (in arbitrary units)
Time frame: immediately before and after intervention (occlusion and exercise)
Oxygen saturation (in %)
Time frame: immediately before and after intervention (occlusion and exercise)
Heart rate (in bpm)
Time frame: immediately before and after intervention (occlusion and exercise)
Blood pressure (in mm Hg)
Time frame: immediately before and after intervention (occlusion and exercise)
Weight (in kg)
Time frame: baseline
Age in years
Time frame: baseline
Gender: male, female, other
Time frame: baseline
Skin tone based on Fitzpatrick questionnaire self-assessment (type 1-6, 1 being the palest, 6 being the darkest)
Time frame: baseline
Dominant side
Time frame: baseline
Sport frequency
Time frame: baseline
Information on last physical exercise and caffeine and alcohol consumption
Time frame: baseline
Quantitative collagen, lipid, water and melanin signal (in arbitrary units)
Time frame: immediately before and after intervention (occlusion and exercise)
Skin tone based on Fitzpatrick scale self-assessment (type 1-6, 1 being the palest, 6 being the darkest)
Time frame: baseline
Skin tone based on Fitzpatrick scale examiner-assessment (type 1-6, 1 being the palest, 6 being the darkest)
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: Yes. Raw data will be transferred to iThera Medical GmbH in anonymized form. iThera Medical GmbH is authorized to further transfer the anonymized data to the American Food and Drug Administration. The study results will be published anonymously in a scientific journal. Additionally, the raw data is planned to be published by the Friedrich-Alexander-University in an open-source manner to serve as reference standard. However it will not be possible to draw conclusions about the identity of the participating individuals.
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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.
Ferdinand Knieling, PD Dr. med. habil. principal investigator
Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 1 inclusion and 7 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 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Felix Wachter (09131 85 41175, felix.wachter@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative hemoglobin-associated signal (in arbitrary units) (time frame: immediately before and after intervention (occlusion and exercise)). 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 7 Aug 2024.