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

Official title

Non-invasive Preoperative Donor-site Evaluation of Free Flaps in Head and Neck Tumor Patients Using Multispectral Optoacoustic Tomography (MSOT)

Overview

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).

Interventions

• Device Multispectral Optoacoustic Tomography (MSOT)
  Non-invasive transcutaneous MSOT imaging of muscle and subcutaneos regions.

Primary outcome measures

• Muscle oxygenation (in arbitrary units) [Time frame: 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.]
• Quantitative hemoglobin-associated signal (in arbitrary units) [Time frame: 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.]

Secondary outcome measures (4)

• Postoperative compromise of microvascular free flaps (Microvascular revision, flap failure) [Time frame: Postoperative observation of the free flap within the stationary visit until dismission (14 days)]
• Oxygen saturation (in %) [Time frame: 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.]
• Questionnaire items (Age, sex, height, weight, BMI, skin type, pre-existing conditions, medication, substance abuse [alcohol, nicotine], moderate physical activity per week) [Time frame: Once at the date of inclusion for the study.]
• Muscle oxygenation (in arbitrary units) [Time frame: 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Germany · 1 center

• University Hospital Erlangen — Erlangen

Identifiers

NCT: NCT06716892 · 24-335-B

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗