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

NCT06541496 | Recruiting FDA Device

• 1 other identifier: cMSOT2-HV-01
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Quantitative hemoglobin-associated signal (in arbitrary units)

  Hemoglobin signal in the measured muscle regions in all different cohorts

  immediately before and after intervention (occlusion and exercise)

Secondary Outcomes (14)

• Muscle oxygenation (in arbitrary units)

  immediately before and after intervention (occlusion and exercise)

• Oxygen saturation (in %)

  immediately before and after intervention (occlusion and exercise)

• Heart rate (in bpm)

  immediately before and after intervention (occlusion and exercise)

• Blood pressure (in mm Hg)

  immediately before and after intervention (occlusion and exercise)

• Weight (in kg)

  baseline

Study Arms (9)

Fitzpatrick 1

Healthy volunteers with skin type 1.

Device: Multispectral Optoacoustic Tomography (MSOT)

Fitzpatrick 2

Healthy volunteers with skin type 2.

Device: Multispectral Optoacoustic Tomography (MSOT)

Fitzpatrick 3

Healthy volunteers with skin type 3.

Device: Multispectral Optoacoustic Tomography (MSOT)

Fitzpatrick 4

Healthy volunteers with skin type 4.

Device: Multispectral Optoacoustic Tomography (MSOT)

Fitzpatrick 5

Healthy volunteers with skin type 5.

Device: Multispectral Optoacoustic Tomography (MSOT)

Fitzpatrick 6

Healthy volunteers with skin type 6.

Device: Multispectral Optoacoustic Tomography (MSOT)

BMI Group 1

Healthy volunteers with BMI \<18.5.

Device: Multispectral Optoacoustic Tomography (MSOT)

BMI Group 2

Healthy volunteers with BMI \>18.5 but \<25.

Device: Multispectral Optoacoustic Tomography (MSOT)

BMI Group 3

Healthy volunteers with BMI \>25.

Device: Multispectral Optoacoustic Tomography (MSOT)

Interventions

Multispectral Optoacoustic Tomography (MSOT) DEVICE

Non-invasive transcutaneous MSOT imaging of muscle regions.

BMI Group 1; BMI Group 2; BMI Group 3; Fitzpatrick 1; Fitzpatrick 2; Fitzpatrick 3; Fitzpatrick 4; Fitzpatrick 5; Fitzpatrick 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Signed informed consent

You may not qualify if:

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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

iThera Medical Headquarters

Munich, Bavaria, 81379, Germany

RECRUITING

Study Officials

• Ferdinand Knieling, PD Dr. med. habil.

  Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix Wachter

CONTACT

09131 85 41175; felix.wachter@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: August 7, 2024
• Study Start: June 14, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)