跳至主要内容
临床试验/NCT01979692
NCT01979692Unknown不适用

Feasibility of Confocal Laser Microscopy CLM in the Computed Tomography-guided Needle Biopsy of Pulmonary and Mediastinal Lesions

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
1
主要终点
The presence of viable tissue at CLM as a marker of accurate histological diagnosis

研究概览

简要总结

The hypothesis of this proposal is that needle confocal laser microscopy (nCLM) may improve the yield of trans thoracic needle biopsy (TTNB) of lung or mediastinal lesions by differentiating between viable and necrotic tissue. This may reduce the number of biopsy attempts and eventually the complication rate of the procedure.

详细描述

CT guided needle biopsy (TTNB - trans thoracic needle biopsy ) of pulmonary lesions is a well established diagnosis technique in pulmonology. It is most suitable for peripheral lung lesions with a diameter greater than 2 cm and for the diagnosis of a mediastinal mass. In these situations the diagnosis yield may reach up to 90% . However in smaller or "non homogenous" lesions (as to CT imaging) the yield lowers to only 60% .As usually there is no rapid onsite specimen pathologic examination (ROSE) a number of attempts (passages) are performed in order to receive a good quality sample. The complication rate of TTNB (pneumothorax or bleeding) is relatively high ( up to 15% and 5% respectively). Necrosis is a common feature of rapid growing tumors and may significantly impair the histopathological diagnosis and thus lowering the TTNB yield. Optimization of the needle position into a viable tissue area of the lesion is imperative as to improve the yield of the TTNB technique.

CLM is an emergent technique in which a low power laser excites the autofluorescence or the induced fluorescence (by intravenous. administration) of tissues. . CLM is capable of to provide the examiner with near histopathological quality tissue imaging serving as an "optical biopsy". The technique is well established in dermatology and gastroenterology (via endoscopes) and serves in distinguishing cellular abnormalities in inflammatory, premalignant and malignant disorders. Recently pulmonary applications were described allowing for alveolar real time vision (alveoscopy) . While used through the working channel of different endoscopes it is named probe CLE ( probe confocal laser endomicroscopy).

Needle based confocal laser endomicroscopy (nCLE) was studied in the diagnostic of pancreatic masses and celiac/mediastinal lymph nodes .A probe CLE was introduced through a 19 G needle biopsy by endoscopic guidance into the lesion. Imaging started following intravenous administration of fluorescein .Preliminary results showed good quality of imaging and also a remarkable positive predictive value of pictures details in normal versus disease tissue .

The CLM probe has a diameter of 0,85 mm and may be introduced through a 19 G trans thoracic biopsy needle by replacing the stylet. Its field of view is of 320 µm , lateral resolution 3,5 µm , depth of 50 µm and length of 4 m. the TTNB will be performed according to the standard protocol at the Interventional Radiology Department at Sheba, following the intravenous administration of fluorescein. This protocol is described further .

After receiving consent, the patient lies on the CT table and the skin over the chest lesion is cleaned and draped in the usual sterile fashion. Local anesthesia is delivered with Lidocaine 2% to the skin and pleura and a 19G introducer needle is advanced to the lesion border under CT vision. Via this introducer a 20G core biopsy needle is advanced and 3-6 biopsies are performed. Following the procedure another CT scan is performed to evaluate for any immediate complications and the patient is transferred to a recovery room for 2 hours observation. Before discharge a chest radiography is performed to evaluate for possible pneumothorax or bleeding.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients aged between 18 and 80 referred for TTNB due to lung or mediastinal lesions. Both genders will be enrolled with new diagnosed mediastinal or lung masses by chest imaging (chest radiography or computed tomographyCT)

排除标准

  • known allergy to anesthetic medication, known allergy to fluorescein, inability to lie on the CT bed examination or cardiovascular instability as decided by the principal investigator.Pregnant women' children or debilitated patients will not be included

结局指标

主要结局

The presence of viable tissue at CLM as a marker of accurate histological diagnosis

时间窗: 24 months

The presence of necrotic tissue in lung or mediastinal biopsies impare the quality of histological diagnosis. CLM may help in distinguishing between viable and necrotic tissue in real time.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Tiberiu Shulimzon MD

Director Interventional Pulmonology

Sheba Medical Center

研究点 (1)

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