Influence of Fitzpatrick Skin Phototype and Body Mass Index on Non-invasive Optoacoustic Imaging

August 5, 2024 updated by: University of Erlangen-Nürnberg Medical School

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81379
        • Recruiting
        • iThera Medical Headquarters
        • Contact:
          • Charlene Reichl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Signed informed consent

Exclusion Criteria:

  • Pregnancy
  • diagnosed diabetes
  • diagnosed renal insufficiency
  • diagnosed Peripheral arterial disease
  • diagnosed muscle associated disease
  • tattoos in scan area
  • missing consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Fitzpatrick 1
Healthy volunteers with skin type 1.
Device: Multispectral Optoacoustic Tomography (MSOT)
Non-invasive transcutaneous MSOT imaging of muscle regions.
Fitzpatrick 2
Healthy volunteers with skin type 2.
Device: Multispectral Optoacoustic Tomography (MSOT)
Non-invasive transcutaneous MSOT imaging of muscle regions.
Fitzpatrick 3
Healthy volunteers with skin type 3.
Device: Multispectral Optoacoustic Tomography (MSOT)
Non-invasive transcutaneous MSOT imaging of muscle regions.
Fitzpatrick 4
Healthy volunteers with skin type 4.
Device: Multispectral Optoacoustic Tomography (MSOT)
Non-invasive transcutaneous MSOT imaging of muscle regions.
Fitzpatrick 5
Healthy volunteers with skin type 5.
Device: Multispectral Optoacoustic Tomography (MSOT)
Non-invasive transcutaneous MSOT imaging of muscle regions.
Fitzpatrick 6
Healthy volunteers with skin type 6.
Device: Multispectral Optoacoustic Tomography (MSOT)
Non-invasive transcutaneous MSOT imaging of muscle regions.
BMI Group 1
Healthy volunteers with BMI <18.5.
Device: Multispectral Optoacoustic Tomography (MSOT)
Non-invasive transcutaneous MSOT imaging of muscle regions.
BMI Group 2
Healthy volunteers with BMI >18.5 but <25.
Device: Multispectral Optoacoustic Tomography (MSOT)
Non-invasive transcutaneous MSOT imaging of muscle regions.
BMI Group 3
Healthy volunteers with BMI >25.
Device: Multispectral Optoacoustic Tomography (MSOT)
Non-invasive transcutaneous MSOT imaging of muscle regions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
immediately before and after intervention (occlusion and exercise)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle oxygenation (in arbitrary units)
Time Frame: immediately before and after intervention (occlusion and exercise)
Oxygenated hemoglobin signal in the measured muscle regions in all different cohorts
immediately before and after intervention (occlusion and exercise)
Oxygen saturation (in %)
Time Frame: immediately before and after intervention (occlusion and exercise)
Proportion of oxygenated hemoglobin signal compared with total hemoglobin signal in the measured muscle regions in all different cohorts
immediately before and after intervention (occlusion and exercise)
Heart rate (in bpm)
Time Frame: immediately before and after intervention (occlusion and exercise)
heart rate of the healthy volunteers
immediately before and after intervention (occlusion and exercise)
Blood pressure (in mm Hg)
Time Frame: immediately before and after intervention (occlusion and exercise)
blood pressure of the healthy volunteers
immediately before and after intervention (occlusion and exercise)
Weight (in kg)
Time Frame: baseline
measured by body scale
baseline
Age in years
Time Frame: baseline
Participant questionnaire.
baseline
Gender: male, female, other
Time Frame: baseline
Participant questionnaire.
baseline
Skin tone based on Fitzpatrick questionnaire self-assessment (type 1-6, 1 being the palest, 6 being the darkest)
Time Frame: baseline
Participant questionnaire.
baseline
Dominant side
Time Frame: baseline
Participant questionnaire.
baseline
Sport frequency
Time Frame: baseline
Participant questionnaire.
baseline
Information on last physical exercise and caffeine and alcohol consumption
Time Frame: baseline
Participant questionnaire.
baseline
Quantitative collagen, lipid, water and melanin signal (in arbitrary units)
Time Frame: immediately before and after intervention (occlusion and exercise)
Signal in the measured muscle regions and the skin (melanin) in all different cohorts
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
color card as reference
baseline
Skin tone based on Fitzpatrick scale examiner-assessment (type 1-6, 1 being the palest, 6 being the darkest)
Time Frame: baseline
color card as reference
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Erlangen-Nürnberg Medical School

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ferdinand Knieling, PD Dr. med. habil., Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • cMSOT2-HV-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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