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临床试验/NCT06844344
NCT06844344招募中不适用

Diagnosing peRipheral Lung Lesions With CRYO Biopsies

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Diagnostic yield

研究概览

简要总结

Lung cancer is the leading course of cancer related deaths world-wide. Lung cancer screening will increase the number of small lung lesion in need of biopsy to confirm the diagnosis. Obtaining lung biopsies with a bronchoscopy has the lowest risk of complications (1-2%) compared to other modalities such as transthoracic needle biopsy (20%), however diagnostic yield needs improvement. Currently a diagnosis is established in 50- 70% of the bronchoscopic procedures depending on the step-up. One way to improve the yield would be by using a cryo probe through the bronchoscope which freezes a small part of the lung for extraction, and thereby provides larger biopsies for examination. This will increase the chances of obtaining sufficient material from a small lesion to determine the diagnosis.

The DR CRYO study will compare cryo biopsies to forceps biopsies for the diagnosis of peripheral lung lesions.

We hope that the cryo biopsies can improve the diagnostic capabilities of bronchoscopy and provide better biopsies for tumor marker analyses. The project is relevant both for patients undergoing diagnostic work-up for lung cancer in early stages .

详细描述

Background:

Lung cancer is currently the leading cause of cancer related deaths world-wide [1]. Approximately 5000 people are diagnosed with lung cancer each year in Denmark [2]. Lung cancer is often detected in late stages of the disease, which are rarely curable and have a poor prognosis [3]. Currently, early stages of lung cancer are often detected incidentally on a computed tomography (CT) scan as a solitary lung lesion [4]. Screening for lung cancer has the possibility to reduce lung cancer mortality, however a screening program will produce a large increase in CT scans with lung lesions [5, 6]. Tissue sampling is one of the corner stones for correctly diagnosing cancer in a patient. Obtaining tissue from the lungs is challenging since the lungs are difficult to access and biopsies comes with risk of complications.

Tissue samples can be acquired either by removing part of the lung surgically, by performing a needle biopsy through the chest wall or by using a bronchoscope (i.e. by endoscopy)-. The latter has the lowest risk of complications, but currently the diagnostic yield is lower than the other two methods. The low risk profile is an advantage in an increasing elderly population, where improvements in the diagnostic capabilities would be of great value to the patients.

Cryo freezing probes enable sampling from the lung parenchyma by freezing a small tissue area which is then extracted via the bronchoscope. The technology was initially invented to provide larger tissue samples for the diagnosis of interstitial lung disease, but may also be of great value for collecting tissue from cancerous disease since cryo biopsies are generally larger and less crushed than traditional biopsies.

Few studies regarding cryo biopsy for sampling cancer in the lungs exists, however initial trials demonstrates higher diagnostic yield and an increase in sufficient material for tumor marker analysis[9, 10].

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •- Patients undergoing diagnostic work-up for lung cancer due to a lung lesion surrounded by normal lung tissue (identified by CT)
  • •Age 18 or above
  • •Bronchoscopy with planned forceps sampling from the lesion

排除标准

  • •- Pregnancy
  • •Not able to provide informed consent.

研究组 & 干预措施

Control

Active Comparator

5 forceps biopsies followed by 5 cryo biopsies

干预措施: forceps biopsies (Diagnostic Test)

Control

Active Comparator

5 forceps biopsies followed by 5 cryo biopsies

干预措施: Cryo biosies (Diagnostic Test)

Intervention

Experimental

5 Cryo biopsies follwed by 5 forcepsbiopsies

干预措施: forceps biopsies (Diagnostic Test)

Intervention

Experimental

5 Cryo biopsies follwed by 5 forcepsbiopsies

干预措施: Cryo biosies (Diagnostic Test)

结局指标

主要结局

Diagnostic yield

时间窗: One week after initial study procedure

\- Total diagnostic yield, being defined as a tissue biopsy allowing a definite diagnosis of either a malignant or benign condition in the lung in proportion to the total number of procedures performed.

次要结局

  • NGS testing(One week after initial study procedure)
  • Malignant yield(One year after initial study procedure)
  • Benign yield(One year after initial study procedure)
  • Complications(One week after bronchoscopy)
  • Serious procedure complications(One week after bronchoscopy)
  • Feasibility of procedure(Same day as the study procedure)
  • tissue grading score(One week after initial study procedure)

研究者

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

Amanda Dandanell Juul

MD, PhD, Senior researcher

Odense University Hospital

研究点 (2)

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