Study Stopped
Technology licensed to third party. Sponsor did not proceed with study.
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
1 other identifier
observational
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2015
CompletedFirst Posted
Study publicly available on registry
May 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedJanuary 26, 2017
January 1, 2017
April 27, 2015
January 25, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
The location of PET imaging agent as measured by beta particle detection
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.
Intraoperatively (during the single session of surgery on Day 0)
The location of PET imaging agent as measured by the LightPathTM Imaging System
The LightPathTM Imaging System will be used for determining the margin status of lesions and the metastatic involvement of lymph nodes.
Intraoperatively (during the single session of surgery on Day 0)
Secondary Outcomes (6)
The number of lesions by histopathology
Expected on average Day 10 after surgery
The number of metastatic lymph nodes by histopathology
Expected on average Day 10 after surgery
The extent of resection margins by histopathology
Expected on average Day 10 after surgery
Ease of use measured by questionnaire
At the end of imaging on Day 0
Radiation exposure
At the time of discharge to the ward after surgery on Day 0
- +1 more secondary outcomes
Study Arms (1)
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).
Interventions
The FDG is injected at least 120 minutes prior to the imaging by the EnLightTM and LightPathTM Imaging Systems
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.
Eligibility Criteria
Female or male patients aged ≥ 30 years diagnosed with gastric, pancreatic, bile duct or duodenal cancer, whose treatment is to be tumour excision surgery.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lightpoint Medical Limitedlead
- Semmelweis Universitycollaborator
Study Sites (1)
Semmelweis University First Clinic of Surgery
Budapest, Budapest, Hungary
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sheryl O'Farrell, PhD
Head of Clinical Development
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2015
First Posted
May 18, 2015
Primary Completion
January 1, 2016
Last Updated
January 26, 2017
Record last verified: 2017-01