Pilot Study of Topographic Imaging of the Gastrocnemius Muscle in Patients With PAD Using Non-invasive Multispectral Optoacoustic Tomography (MSOT) as a 3D Reconstruction Based on Longitudinal 2D Measurements
试验速览
- 阶段
- 不适用
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- MSOT topogram showing MSOT parameters from 660 up to 1100 nm of the gastrocnemius muscle
研究概览
简要总结
The aim of this explorative pilot study is to present muscle perfusion of the lower extremity in patients with PAD using the Multispectral Optoacoustic Tomography (MSOT) method to build a 3D reconstruction of the calf muscle. This study aims to show the feasibility of 3D reconstruction of this non-invasive method. Advantages in diagnostics for patients with PAD and three-dimensional tomography representation of the perfusion situation based on muscle oxygenation will be evaluated.
详细描述
Functional imaging diagnostics is becoming increasingly important due to the steadily growing knowledge of physiological processes in many diseases. Also in peripheral arterial occlusive disease (PAD), new insights into the pathomechanism of the disease are continuously being gained. This also increases the need for new non-invasive imaging methods that are able to visualize the functional level of the disease progression and thus make it possible to diagnose it at an early stage.
Recent studies indicate that it may be feasible to use multispectral optoacoustic tomography (MSOT) to visualize hemodynamics as well as the fibrotic muscle remodeling process in PAD. For a better understanding of the distribution pattern , the exploration of a 3D technique is a next necessary step in imaging. This may show a possible existing heterogeneity of these molecules.
Holzwarth et al. were already able to gain knowledge about the 3D reconstruction from 2D photoacoustic image slices using an optical pattern and the method's feasibility using phantoms as well as in-vivo measurements of the forearm in healthy volunteers.
The aim of this exploratory pilot project is to bring these previous findings together and to image muscle perfusion of the lower extremity in three dimensions using the MSOT method and to verify its feasibility. The advantage of 3D imaging is, beyond the anatomical topography of the muscle, to map a three-dimensional representation of the perfusion situation based on muscle oxygenation.
For this purpose, six patients of different symptomatic PAD stages and a healthy control of two volunteers will be included and examined by means of longitudinal MSOT scans in the area of the gastrocnemius muscle. To evaluate the current stage of the disease or to exclude relevant PAD in the healthy control population, non-invasive examination measures commonly used in routine diagnostics of PAD will be applied. In addition to the relevant risk factors/adjacent diseases and the current medication intake, these include the recording of the ankle-brachial index (ABI), color-coded duplex sonographic vascular imaging (CCDS) and a treadmill examination.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients with manifest PAD stages II-IV according to Fontaine or healthy volunteers
- •Adult (>18 years) persons who are able to give their consent
排除标准
- •Patients with PAD stage I according to Fontaine
- •Healthy volunteers with pre-existing diabetes mellitus, chronic renal failure, or abnormal ABI
- •Underage persons
- •Missing consent form
- •Exclusion due to safety concerns of the study physician (patient with a physical, mental or psychiatric illness which, in the opinion of the study physician, would compromise the safety of the patient or the quality of the data and thus make the patient an unsuitable candidate for the study)
结局指标
主要结局
MSOT topogram showing MSOT parameters from 660 up to 1100 nm of the gastrocnemius muscle
时间窗: single time point (1 day)
MSOT topogram using 3D reconstruction based on longitudinal 2D scans trough an optical pattern showing MSOT parameters from 660 up to 1100 nm of the gastrocnemius muscle
次要结局
- Acquisition of the current walking distance standardized by treadmill examination(single time point (1 day))
- Acquisition of static 2D MSOT measurements before and after gait exposure(single time point (1 day))
- Validation of the accuracy of the MSOT 3D reconstruction using an overlay from MRA(single time point (1 day))
- Recording of relevant patient data from the patient's file(single time point (1 day))
- Acquisition of the quantitative hemoglobin signal (oxygenated/deoxygenated)(single time point (1 day))
- 3D reconstruction of the longitudinal measurements using two different pattern designs(single time point (1 day))
- Acquisition of the flow profile of the common femoral artery and popliteal artery using CCDS(single time point (1 day))
- Acquisition of the quantitative fibrosis signals (collagen/lipid)(single time point (1 day))
- Acquisition of the Ankle-Brachial-Index(single time point (1 day))
- Acquisition of the PAD stage according to Fontaine and Rutherford(single time point (1 day))
研究者
Ulrich Rother
PD Dr. med.
University Hospital Erlangen