Investigating how skin type and body weight affect optoacoustic imaging
Influence of Fitzpatrick Skin Phototype and Body Mass Index on Non-invasive Optoacoustic Imaging of Muscle During Vascular Restriction and Physical Activity
University of Erlangen-Nürnberg Medical School · NCT06541496
This study is testing how different skin types and body weights affect the accuracy of a special imaging technique that looks at blood flow and oxygen in muscles, using healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School (other) |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT06541496 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the influence of Fitzpatrick skin phenotypes and body mass index on muscle perfusion and oxygenation using Multispectral Optoacoustic Tomography (MSOT). Healthy volunteers with varying skin tones and BMI will undergo leg arterial occlusion and toe raise exercises, followed by imaging scans on different body areas. The study seeks to understand how melanin content and body weight may affect the accuracy of optoacoustic imaging measurements, which could improve the technology's application in clinical settings.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults with varying Fitzpatrick skin types and body mass indices.
Not a fit: Patients with conditions such as diabetes, renal insufficiency, or peripheral arterial disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of optoacoustic imaging for assessing muscle health across diverse populations.
How similar studies have performed: While there have been studies on melanin's effect on other imaging technologies, this specific approach using MSOT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Munich, Bavaria
- iThera Medical Headquarters — Munich, Bavaria, Germany (RECRUITING)
Study contacts
- Principal investigator: Ferdinand Knieling, PD Dr. med. habil. — Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen
- Study coordinator: Felix Wachter
- Email: felix.wachter@uk-erlangen.de
- Phone: 09131 85 41175
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy