Non-invasive Preoperative Donor-site Evaluation of Free Flaps in Head and Neck Tumor Patients Using Multispectral Optoacoustic Tomography (MSOT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Muscle oxygenation (in arbitrary units)
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cohort 1: Histopathological diagnosed head and neck tumor patients.
- •Cohort 2: Healthy adults.
排除标准
- •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.
结局指标
主要结局
Muscle oxygenation (in arbitrary units)
时间窗: 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)
时间窗: 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.
次要结局
- Postoperative compromise of microvascular free flaps (Microvascular revision, flap failure)(Postoperative observation of the free flap within the stationary visit until dismission (14 days))
- 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.)
- 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.)
- 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.)