Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541496
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-24
Brief Title:
Influence of Fitzpatrick Skin Phototype and Body Mass Index on Non-invasive Optoacoustic Imaging
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Influence of Fitzpatrick Skin Phototype and Body Mass Index on Non-invasive Optoacoustic Imaging of Muscle During Vascular Restriction and Physical Activity
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None