Use of the EnLightTM and LightPathTM Imaging Systems in Gastrointestinal Tumour Surgery (CLIO)
Evaluation of the Use of Intra-operative Molecular Imaging With BetaScope and in Vitro Measurement With LightPath Specimen Analyser Devices in Gastrointestinal Tumour Surgery
This study will evaluate the performance of the EnLightTM and LightPathTM Imaging Systems in detecting tumour lesions in patients with gastric, pancreas, bile duct or duodenal cancer.
EnLightTM will be used to detect positron emission and the LightPathTM system to detect Cerenkov Luminescence. Both are emitted by the Positron Emission Tomography (PET) agent.
The study will also evaluate the patient safety and radiation safety of the EnLightTM, and the safety for the device operators and surgical staff of the LightPathTM Imaging System.
研究概览
地位
详细说明
This is a pilot study that is prospective, open-label, single-centre in nature in patients with gastric, pancreas, bile duct or duodenal cancer in whom tumour excision surgery is indicated.
Patients who give written informed consent will be screened for the study (Visit 1). Patients will undergo a positron emission tomography (PET) whole body scan. Screening assessments, including the PET scan, must be performed no less than 60 days before surgery and may be performed on the day of surgery.
On the day of surgery (Visit 2), subject's blood glucose level will be measured. Subjects with a blood glucose level < 12 mmol/l will receive an intravenous injection of 2-5 Mega Becquerel/kg (MBq/kg), up to a maximum 300 MBq of fluorine-18 fluorodeoxyglucose (18F-FDG) prior to surgery.
During surgery and not less than 120 minutes after injection of FDG, the primary lesion will be imaged using the EnLightTM system to determine margin status.
Gastrointestinal tumour excision surgery will then be performed according to standard of care. The surgical cavity and the lymph nodes will be imaged by the EnLightTM system to establish whether other radioactive tissue remain. These results will not influence any surgical or clinical decision-making, which will remain as standard of care. The resected tumour excision specimen will be imaged by the LightPathTM Imaging System. The resected tumour excision specimen will, in addition, be analysed according to standard of care pathology. The surgeon and surgical staff will be monitored for external exposure to ionizing radiation by means of dosimeters, and position sensors during surgery.
Patients will be followed-up (Visit 3) within a 2 - 14 day window after the end of surgery for adverse events (AEs). Those related to the use of the investigational devices, or the PET imaging agent will be identified as such.
研究类型
联系人和位置
学习地点
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Budapest、匈牙利
- Semmelweis University First Clinic of Surgery
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Provides written informed consent to participate in the study.
- Is a man or woman aged ≥ 30 years.
- Patients diagnosed with gastric, pancreatic, bile duct or duodenal cancer whose treatment is to be tumour excision surgery.
- Life expectancy of at least 12 months.
- Blood glucose level < 12 mmol/l.
Exclusion Criteria:
- Participation in another clinical study either concurrently or within 180 days prior to surgery.
- Major surgery within 30 days before the baseline visit.
- Women who are pregnant or lactating.
- Renal impairment, hepatic impairment, serious infection or other life-threatening illness, other than cancer, within 60 days before surgery.
- Previous exposure to ionizing radiation >5 millisieverts (mSv) in the previous 12 months.
学习计划
研究是如何设计的？
设计细节
- 观测模型：其他
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
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EnLightTM and LightPathTM Imaging Systems arm
Patients will first be injected intravenously with 2-5 MBq/kg, up to a maximum 300 MBq of the marketed product 18F-fluorodeoxyglucose (FDG) and after this undergo tumour excision surgery according to standard of care. The surgical cavity will be imaged by the EnLightTM system and the tumour excision specimen will be imaged by both the EnLightTM and LightPathTM Imaging Systems. The EnLightTM and LightPathTM Imaging Systems results will not influence any surgical or clinical decision-making. The tumour excision specimen will be analysed according to standard of care pathology. Patients will be followed-up (Visit 3) 2-14 days after the end of surgery for adverse events (AEs). |
The FDG is injected at least 120 minutes prior to the imaging by the EnLightTM and LightPathTM Imaging Systems
其他名称：
The surgical cavity and the resected lymph nodes (if any) will be imaged by the EnLightTM system to establish whether radioactive tissue remains after surgery.
The resected tumour excision specimens and the resected lymph nodes (if any)will be imaged by CLI and by WLI to establish whether they contain radioactive tissue.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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The location of PET imaging agent as measured by beta particle detection
大体时间：Intraoperatively (during the single session of surgery on Day 0)
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The EnLightTM will be used for determining the number of lesions, their location and margin status, in the surgical cavity including within surrounding tissue, and lymph nodes.
The EnLightTM is a beta particle detector used for imaging the location of the PET imaging agent.
It works both in a hot-spot mode, to localise areas with high beta particle detection signal from the PET imaging agent, and in an imaging mode that allows video imaging of areas where the PET imaging agent has accumulated.
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Intraoperatively (during the single session of surgery on Day 0)
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The location of PET imaging agent as measured by the LightPathTM Imaging System
大体时间：Intraoperatively (during the single session of surgery on Day 0)
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The LightPathTM Imaging System will be used for determining the margin status of lesions and the metastatic involvement of lymph nodes.
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Intraoperatively (during the single session of surgery on Day 0)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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The number of lesions by histopathology
大体时间：Expected on average Day 10 after surgery
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Number of lesions according to standard of care histopathology.
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Expected on average Day 10 after surgery
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The number of metastatic lymph nodes by histopathology
大体时间：Expected on average Day 10 after surgery
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The number of metastatic lymph nodes according to standard of care histopathology.
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Expected on average Day 10 after surgery
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The extent of resection margins by histopathology
大体时间：Expected on average Day 10 after surgery
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Extent of resection margins according to standard of care histopathology.
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Expected on average Day 10 after surgery
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Ease of use measured by questionnaire
大体时间：At the end of imaging on Day 0
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Ease of use measured by study-specific questionnaire
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At the end of imaging on Day 0
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Radiation exposure
大体时间：At the time of discharge to the ward after surgery on Day 0
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Radiological dose in microsieverts as measured by dosimeters worn by operating room staff
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At the time of discharge to the ward after surgery on Day 0
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Number of participants with adverse events
大体时间：Visit 3, at day 3-15
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Patients will be followed-up until Visit 3, 2-14 days after the end of surgery on Day 0 for adverse events
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Visit 3, at day 3-15
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合作者和调查者
调查人员
- 研究主任：Sheryl O'Farrell, PhD、Head of Clinical Development
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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