Investigation of Lipedema, Lymphedema and Vascular Malformations by Multispectral Optoacoustic Tomography (MSOT)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visualization of subcutaneous fatty tissue
研究概览
简要总结
This study aims to analyze the fatty tissue architecture of the subcutaneous tissue in patients from the plastic surgery department.
Plastic surgery patients show a wide variety of subcutaneous fatty tissue structures during clinical examination. These include patients with edema of the extremities such as lipedema or lymphedema.
Fatty tissue architecture plays a major role in our everyday lives, as wound healing and scar formation, for example, are influenced by the blood flow to the overlying skin. The fatty tissue architecture, especially in the subcutaneous fatty tissue, also plays a major role in our appearance. An analysis of the architecture can potentially provide information about the genesis of different skin fold formations. The aim of this study is to quantitatively describe structural differences in adipose tissue architecture.
Adipose tissue architecture is still a largely unexplored area because imaging has not been possible to date. MSOT imaging is similar to conventional sonography in that a transducer is placed on the skin and energy is supplied to the tissue by pulsed laser light instead of sound. On a macroscopic level, this leads to a constant change of minimal oscillations of individual tissue components. The resulting sound waves can then be detected by the same transducer. Previous studies have shown that the quantitative determination of hemoglobin can be used to obtain information on blood circulation and inflammatory activity. In the extended spectrum, in contrast, not only hemoglobin and its oxygenation stages but also other biomarkers such as collagens and lipids can be detected. This is very useful for imaging of fat, lymphatics and normal and abnormal blood vessels in vascular malformations.
This process was largely researched by the working group of Prof. Ntziachristos (Helmholtz Center Munich and Technical University of Munich) and Prof. Razansky (Eidgenösische Technische Hochschule Zurich) and is being further developed into a clinically applicable technology and sold commercially by the company iThera. As a first series of demonstrative clinical studies following rigorous technical development, MSOT will serve as a key tool for research partners in the investigation of several diseases that remain poorly-understood and have limited treatment options. These parallel studies will focus on lipedema and lymphedema as well as vascular malformations - three distinct disease groups with similarly unmet clinical needs for appropriate imaging modalities and high potential of translation to further major disease areas. By focusing on two unrelated diseases, this project will show the wide-reaching application of this innovative imaging approach. Following successful proof-of-principle validation in a clinical research environment, full exploitation and dissemination of the results will strive to deliver MSOT to the greater scientific community. The main objectives are to confirm/validate the spectral profile of fat and vasculature on MSOT in lipedema patients, to establish the spectral profile of vascular malformations based on MSOT for adults and children and to establish the spectral profile and imaging of lymphatic vessels.
With a detailed analysis of the architecture, our understanding of the physiology and pathology of the skin may be enhanced.
详细描述
To date, the diagnostic path of illnesses involving an altered adipose tissue architecture are usually slow and depend heavily on the experience of the examiner, so it often takes several years before the patient is properly treated. Current imaging methods for the quantitative assessment of subcutaneous fat tissue only provide non-specific findings. With our study, the investigators present a novel imaging method for examining adipose tissue.
Optoacoustics is an innovative hybrid imaging method that combines the high contrast of optical imaging with the high resolution of acoustics. The MSOT system used consists of a laser in the visible near-infrared and far-infrared wavelength range (660nm -1300nm) and an ultrasonic sensor connected to a computer. Using optical components, the area to be measured is illuminated with ultra-short light pulses of selectable wavelength. The light is absorbed to varying degrees inside the object - depending on the properties of the tissue. The Laser light stimulates chromophores such as hemoglobin or melanin in the human body, which results in an expansion and subsequent contraction of the tissue, the so-called thermoelastic effect. The local microscopic volume fluctuations emit pressure waves in the ultrasonic range (photoacoustic effect). The skin surface is scanned using high-precision microstages. At each location, the ultrasound signals generated by the light pulse are recorded tomographically outside the object using the detector and stored on the computer. With the help of special algorithms, the properties of the tissue can be reconstructed on the computer from the measured ultrasound signal. MSOT enables non-invasive, non-ionizing imaging with high spatial resolution (80 μm), which enables specific visualization of endogenous tissue pigments such as collagen fibers, fat, melanin, oxyhemoglobin and deoxyhemoglobin. Lasers for stimulating certain chromophores are already in wide therapeutic use in dermatology; their effects and side effects are known and are minimal to non-existent when a suitable energy is selected. The penetration depth of MSOT is significantly greater compared to other optical imaging methods.
In addition, this non-invasive, real-time measuring system can be used in numerous everyday clinical questions that otherwise require more invasive methods like CT or MRI. Apart from the examination of fatty tissue architecture, MSOT could be used pre- and perioperatively to visualize vessels, for example to optimize or even primarily enable the perfusion of flaps. The aim is to display and analyze the architecture of the subcutaneous fatty tissue in plastic surgery patients using MSOT.
The study is designed as a prospective cohort study of subjects recruited from the plastic surgery patient population. MSOT measurements are carried out on 50 subjects with clinically healthy subcutaneous fatty tissue and 50 subjects with changes in the subcutaneous fatty tissue (e.g. lipedema). The recorded data is quantified and compared.
The test subjects for this study are recruited from the trauma surgery, orthopedics and plastic surgery clinic and polyclinic. In particular, patients are recruited from the special plastic surgery consultation hours.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Typical tenderness in the calf, back of the knee or lateral thigh
- •Tendency to hematoma in areas affected by edema
- •Typical inspection disorder of fatty tissue distribution with dent formation, asymmetry in lateral comparison and increased circumference
- •Tendency to edema throughout the day with typical feeling of pressure/pain
- •Unsuccessful conservative therapy attempts and weight loss attempts.
排除标准
- •Age <18 or >80
- •pregnancy and breastfeeding
- •Lack of voluntary consent
结局指标
主要结局
Visualization of subcutaneous fatty tissue
时间窗: After inclusion of the subject the architecture of the subcutaneous fatty is visualized one time at baseline. There will be only one examination of each patient.
The aim is to display and analyze the architecture of the subcutaneous fatty tissue in plastic surgery patients using MSOT
次要结局
未报告次要终点
研究者
Laura Hansen
Laura Hansen, Resident Physician, Department of Plastic and Reconstructive Surgery
University Hospital Goettingen
