Non-invasive Preoperative Tissue Evaluation in Head and Neck Tumor Patients Using Multispectral Optoacoustic Tomography (MSOT)

Recruiting

• Conditions: Head and Neck Cancer; Healthy

• Registration Number: NCT06716892
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief Summary

Multispectral Optoacoustic Tomography (MSOT) is a promising imaging technology that utilizes pulsed laser light. One of the key capabilities of this technology is measuring oxygenation within human tissue. This proposed study aims to investigate possible limitations of human tissue used for reconstructive surgery due to flawed tissue perfusion.

Healthy volunteers as well as patients with a diagnosed head and neck cancer entity will be recruited. Both cohorts will then be scanned on different body areas (most common tissue sites used for reconstructive surgery on the back, arms and legs) to assess differences in muscle oxygenation between the healthy and tumor patient cohort using MSOT.

The hypothesis of the study is, that patients with diagnosed head and neck cancer entities are prone to compromised tissue perfusion due to a high prevalence of smoking within the head neck tumor patient cohort and therefore perfusion restirciting diseases e.g. peripheral arterial occlusive disease (PAOD).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-28
• Study First Submitted: 2024-11-29
• Study First Submitted QC: 2024-11-29
• Last Update Submitted: 2024-11-29
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Cohort 1: Histopathological diagnosed head and neck tumor patients.
• Cohort 2: Healthy adults.

Exclusion Criteria

• Pregnancy / breastfeeding
• ink / tattoo in the areas of interest (upper back, distal forearm, upper and lower leg)
• missing consent form
• Cohort 2: Chronical abuse of alcohol and nicotine.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Muscle oxygenation (in arbitrary units)	Immediately before and after intervention (exercise) within both cohorts. Within the cohort of head and neck tumor patients, possible postoperative second measurement of the transplanted tissue after performed reconstructive surgery.	Oxygenated hemoglobin signal in the measured muscle regions in all different cohorts.
Quantitative hemoglobin-associated signal (in arbitrary units)	Immediately before and after intervention (exercise) within both cohorts. Within the cohort of head and neck tumor patients, possible postoperative second measurement of the transplanted tissue after performed reconstructive surgery.	Hemoglobin signal in the measured muscle regions in all different cohorts.

Secondary Outcome Measures

Name	Time	Method
Postoperative compromise of microvascular free flaps (Microvascular revision, flap failure)	Postoperative observation of the free flap within the stationary visit until dismission (14 days)	Correlation between preoperative accquired MSOT parameters (e.g. quantitative hemoglobin-associated signal, muscle oxygenation, oxygen saturation) in the head and neck cancer cohort and the clinical outcome of the reconstructive surgery (Microvascular revision, flap failure).
Oxygen saturation (in %)	Immediately before and after intervention (exercise) within both cohorts. Within the cohort of head and neck tumor patients, possible postoperative second measurement of the transplanted tissue after performed reconstructive surgery.	Proportion of oxygenated hemoglobin signal compared with total hemoglobin signal in the measured muscle regions in all different cohorts
Questionnaire items (Age, sex, height, weight, BMI, skin type, pre-existing conditions, medication, substance abuse [alcohol, nicotine], moderate physical activity per week)	Once at the date of inclusion for the study.	Questionnaire items for both the healthy and the head and neck tumor cohort.
Muscle oxygenation (in arbitrary units)	Immediately before and after intervention (exercise) within both cohorts. Within the cohort of head and neck tumor patients, possible postoperative second measurement of the transplanted tissue after performed reconstructive surgery.	Oxygenated hemoglobin signal in the measured muscle regions in all different cohorts.

Trial Locations

Locations (1)

University Hospital Erlangen; 🇩🇪 Erlangen, Bavaria, Germany