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

Официальное название

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

Обзор

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).

Вмешательства

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

Первичные конечные точки

• Muscle oxygenation (in arbitrary units) [Срок оценки: 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) [Срок оценки: 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.]

Вторичные конечные точки (4)

• Postoperative compromise of microvascular free flaps (Microvascular revision, flap failure) [Срок оценки: Postoperative observation of the free flap within the stationary visit until dismission (14 days)]
• Oxygen saturation (in %) [Срок оценки: 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) [Срок оценки: Once at the date of inclusion for the study.]
• Muscle oxygenation (in arbitrary units) [Срок оценки: 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.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 1 центр

• University Hospital Erlangen — Erlangen

Идентификаторы

NCT: NCT06716892 · 24-335-B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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