Non-invasive MSOT Examination of Muscle Oxygenation in Athletes and PAD Patients

NCT ID: NCT07347535

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-08-01

Brief Summary

The aim of the study is to present the quantitative differences in oxygenated hemoglobin in different cohorts.

This clinical study evaluates whether there is a correlation between measurements using multispectral optoacoustic tomography and the results of spiroergometry in the context of performance diagnostics.

Detailed Description

This study aims to investigate the muscle metabolism of athletes (endurance and strength athletes), PAD patients, and healthy control subjects using non-invasive multispectral optoacoustic tomography as part of interval treadmill spiroergometry. The aim is to take a closer look at changes in oxygen supply and muscle metabolism in the various patient groups during the recovery phase. To this end, the individual groups will perform a performance diagnosis on a treadmill spiroergometer, adapted to their respective estimated physical performance (in the case of PAD patients, taking into account the possibilities given by the disease), which will be carried out in the form of a step test. In addition, MSOT measurements will be taken between the individual steps.

The aim of this study is to use MSOT to visualize and compare the muscle perfusion-in particular the proportion of oxygenated and deoxygenated hemoglobin (Hb)-of the various cohorts, as well as to compare it with the diagnostics and methods commonly used to date and identify any advantages. In the future, this could contribute to a better understanding of muscle perfusion, especially in connection with diseases such as PAD or other muscle lesions in sports medicine.

Conditions

PAD - Peripheral Arterial Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PAD - peripheral artery disease

Patients with PAD

MSOT - Multispectral optoacustic tomography

Intervention Type: DIAGNOSTIC_TEST

MSOT is an advanced imaging technology that combines laser-induced ultrasound and light absorption to visualize biological tissues. By detecting ultrasound waves generated from tissue absorption of multispectral light, MSOT provides high-resolution, real-time images with functional and molecular information. One of its use is in biomedical research and clinical applications to study blood oxygenation and tissue composition, making it valuable for areas such as vascular research. In this study, we aim to utilize MSOT to differentiate between venous, arteriovenous and lymphatic malformations.

CPET

Intervention Type: DIAGNOSTIC_TEST

Spiroergometry (also called cardiopulmonary exercise testing, CPET) is a diagnostic test that measures how the heart, lungs, and muscles work together during physical activity. While a person performs exercise treadmill the test records breathing gases (oxygen uptake and carbon dioxide output), ventilation, heart rate, and workload.

It provides valuable information about aerobic capacity, endurance, and limitations caused by cardiovascular, pulmonary, or metabolic conditions, making it useful in sports medicine, rehabilitation, and clinical diagnostics.

Triathletes

very fit subjects, who do triathlon

MSOT - Multispectral optoacustic tomography

Intervention Type: DIAGNOSTIC_TEST

MSOT is an advanced imaging technology that combines laser-induced ultrasound and light absorption to visualize biological tissues. By detecting ultrasound waves generated from tissue absorption of multispectral light, MSOT provides high-resolution, real-time images with functional and molecular information. One of its use is in biomedical research and clinical applications to study blood oxygenation and tissue composition, making it valuable for areas such as vascular research. In this study, we aim to utilize MSOT to differentiate between venous, arteriovenous and lymphatic malformations.

CPET

Intervention Type: DIAGNOSTIC_TEST

Spiroergometry (also called cardiopulmonary exercise testing, CPET) is a diagnostic test that measures how the heart, lungs, and muscles work together during physical activity. While a person performs exercise treadmill the test records breathing gases (oxygen uptake and carbon dioxide output), ventilation, heart rate, and workload.

It provides valuable information about aerobic capacity, endurance, and limitations caused by cardiovascular, pulmonary, or metabolic conditions, making it useful in sports medicine, rehabilitation, and clinical diagnostics.

Strength athletes

Strength athletes and bodybuilders

MSOT - Multispectral optoacustic tomography

Intervention Type: DIAGNOSTIC_TEST

MSOT is an advanced imaging technology that combines laser-induced ultrasound and light absorption to visualize biological tissues. By detecting ultrasound waves generated from tissue absorption of multispectral light, MSOT provides high-resolution, real-time images with functional and molecular information. One of its use is in biomedical research and clinical applications to study blood oxygenation and tissue composition, making it valuable for areas such as vascular research. In this study, we aim to utilize MSOT to differentiate between venous, arteriovenous and lymphatic malformations.

CPET

Intervention Type: DIAGNOSTIC_TEST

Spiroergometry (also called cardiopulmonary exercise testing, CPET) is a diagnostic test that measures how the heart, lungs, and muscles work together during physical activity. While a person performs exercise treadmill the test records breathing gases (oxygen uptake and carbon dioxide output), ventilation, heart rate, and workload.

It provides valuable information about aerobic capacity, endurance, and limitations caused by cardiovascular, pulmonary, or metabolic conditions, making it useful in sports medicine, rehabilitation, and clinical diagnostics.

young, unathletic group

Young, healthy and unathletic subjects between 18 - 40 years

MSOT - Multispectral optoacustic tomography

Intervention Type: DIAGNOSTIC_TEST

MSOT is an advanced imaging technology that combines laser-induced ultrasound and light absorption to visualize biological tissues. By detecting ultrasound waves generated from tissue absorption of multispectral light, MSOT provides high-resolution, real-time images with functional and molecular information. One of its use is in biomedical research and clinical applications to study blood oxygenation and tissue composition, making it valuable for areas such as vascular research. In this study, we aim to utilize MSOT to differentiate between venous, arteriovenous and lymphatic malformations.

CPET

Intervention Type: DIAGNOSTIC_TEST

Spiroergometry (also called cardiopulmonary exercise testing, CPET) is a diagnostic test that measures how the heart, lungs, and muscles work together during physical activity. While a person performs exercise treadmill the test records breathing gases (oxygen uptake and carbon dioxide output), ventilation, heart rate, and workload.

It provides valuable information about aerobic capacity, endurance, and limitations caused by cardiovascular, pulmonary, or metabolic conditions, making it useful in sports medicine, rehabilitation, and clinical diagnostics.

older, unathletic group

older, unathletic and healthy subjects between 55 - 75 years

MSOT - Multispectral optoacustic tomography

Intervention Type: DIAGNOSTIC_TEST

MSOT is an advanced imaging technology that combines laser-induced ultrasound and light absorption to visualize biological tissues. By detecting ultrasound waves generated from tissue absorption of multispectral light, MSOT provides high-resolution, real-time images with functional and molecular information. One of its use is in biomedical research and clinical applications to study blood oxygenation and tissue composition, making it valuable for areas such as vascular research. In this study, we aim to utilize MSOT to differentiate between venous, arteriovenous and lymphatic malformations.

CPET

Intervention Type: DIAGNOSTIC_TEST

Spiroergometry (also called cardiopulmonary exercise testing, CPET) is a diagnostic test that measures how the heart, lungs, and muscles work together during physical activity. While a person performs exercise treadmill the test records breathing gases (oxygen uptake and carbon dioxide output), ventilation, heart rate, and workload.

It provides valuable information about aerobic capacity, endurance, and limitations caused by cardiovascular, pulmonary, or metabolic conditions, making it useful in sports medicine, rehabilitation, and clinical diagnostics.

training PAD Patients

MSOT - Multispectral optoacustic tomography

Intervention Type: DIAGNOSTIC_TEST

MSOT is an advanced imaging technology that combines laser-induced ultrasound and light absorption to visualize biological tissues. By detecting ultrasound waves generated from tissue absorption of multispectral light, MSOT provides high-resolution, real-time images with functional and molecular information. One of its use is in biomedical research and clinical applications to study blood oxygenation and tissue composition, making it valuable for areas such as vascular research. In this study, we aim to utilize MSOT to differentiate between venous, arteriovenous and lymphatic malformations.

CPET

Intervention Type: DIAGNOSTIC_TEST

Spiroergometry (also called cardiopulmonary exercise testing, CPET) is a diagnostic test that measures how the heart, lungs, and muscles work together during physical activity. While a person performs exercise treadmill the test records breathing gases (oxygen uptake and carbon dioxide output), ventilation, heart rate, and workload.

It provides valuable information about aerobic capacity, endurance, and limitations caused by cardiovascular, pulmonary, or metabolic conditions, making it useful in sports medicine, rehabilitation, and clinical diagnostics.

Interventions

MSOT - Multispectral optoacustic tomography

MSOT is an advanced imaging technology that combines laser-induced ultrasound and light absorption to visualize biological tissues. By detecting ultrasound waves generated from tissue absorption of multispectral light, MSOT provides high-resolution, real-time images with functional and molecular information. One of its use is in biomedical research and clinical applications to study blood oxygenation and tissue composition, making it valuable for areas such as vascular research. In this study, we aim to utilize MSOT to differentiate between venous, arteriovenous and lymphatic malformations.

Intervention Type: DIAGNOSTIC_TEST

CPET

Spiroergometry (also called cardiopulmonary exercise testing, CPET) is a diagnostic test that measures how the heart, lungs, and muscles work together during physical activity. While a person performs exercise treadmill the test records breathing gases (oxygen uptake and carbon dioxide output), ventilation, heart rate, and workload.

It provides valuable information about aerobic capacity, endurance, and limitations caused by cardiovascular, pulmonary, or metabolic conditions, making it useful in sports medicine, rehabilitation, and clinical diagnostics.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years (adults capable of giving consent)
• Capacity to consent. The subjects are able to understand the information provided and give their written consent.
• Belonging to one of the following cohorts:
• Endurance athletes: at least 3× per week ≥ 60 minutes of intensive endurance training (e.g., running, cycling, swimming)
• Strength athletes: at least 3× per week ≥ 60 minutes of intensive strength training without additional endurance training
• Healthy control subjects: less than 2× per week < 30 minutes of physical activity, no known vascular diseases
• PAD patients: diagnosed peripheral arterial occlusive disease in Fontaine stage I or IIa Women of childbearing age with or without contraception may participate, as there are no risks of harm to the fetus.
• Consent to pseudonymized data collection and storage in accordance with the GDPR.

Exclusion Criteria

• Age over 75 years
• Minors (Age < 18)
• safety concerns on the part of the study physician, e.g., in the case of of: physical, mental or psychiatric illnesses, acute or chronic conditions that could jeopardise safety or data quality
• Taking medications that could affect physical performance or physiological measurements (e.g., heart rate, oxygen uptake).
• Pregnancy with known risks or complications (participation is possible in principle, but subject to individual medical review).
• Refusal to participate or lack of informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PD Dr. med. Ferdinand Knieling, Department of pediatrics, University of Erlangen-Nürnberg

UNKNOWN

Sponsor Role: collaborator

University Hospital Erlangen

OTHER

Sponsor Role: lead

Responsible Party

Ulrich Rother

Senior Consultant, Department of Vascular Surgery, University Hospital Erlangen

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MSOT_SPO2RT

Identifier Type: -

Identifier Source: org_study_id