Gastric CancerCLIONCT02446379
Use of the EnLightTM and LightPathTM Imaging Systems in Gastrointestinal Tumour Surgery
An observational study of Gastric Cancer and Pancreatic Cancer, run by Lightpoint Medical Limited at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Gastric Cancer, Pancreatic Cancer, Bile Duct Cancer
- What is being tested?
- The marketed product 2-5 MBq/kg 18F-fluorodeoxyglucose, EnLightTM and LightPathTM Imaging System
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 0 participants
- Where
- 1 siteHungary
- Study dates
- Start not givento 1 Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Female or male patients aged ≥ 30 years diagnosed with gastric, pancreatic, bile duct or duodenal cancer, whose treatment is to be tumour excision surgery.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University First Clinic of Surgery
Budapest, Budapest
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Gastric Cancer, Pancreatic Cancer, Bile Duct Cancer, Duodenal Cancer
- Being tested
- The marketed product 2-5 MBq/kg 18F-fluorodeoxyglucose, EnLightTM, LightPathTM Imaging System
- Medical subject headings
- Stomach Neoplasms, Pancreatic Neoplasms, Bile Duct Neoplasms, Duodenal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The marketed product 2-5 MBq/kg 18F-fluorodeoxyglucoseDrug
Also called FDG
The FDG is injected at least 120 minutes prior to the imaging by the EnLightTM and LightPathTM Imaging Systems
EnLightTMDevice
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.
LightPathTM Imaging SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: The marketed product 2-5 MBq/kg 18F-fluorodeoxyglucose; Device: EnLightTM; Device: LightPathTM Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Intraoperatively (during the single session of surgery on Day 0)
Secondary outcomes (6)
The number of lesions by histopathology
Number of lesions according to standard of care histopathology.
Measured: Expected on average Day 10 after surgery
The number of metastatic lymph nodes by histopathology
The number of metastatic lymph nodes according to standard of care histopathology.
Measured: Expected on average Day 10 after surgery
The extent of resection margins by histopathology
Extent of resection margins according to standard of care histopathology.
Measured: Expected on average Day 10 after surgery
Ease of use measured by questionnaire
Ease of use measured by study-specific questionnaire
Measured: At the end of imaging on Day 0
Radiation exposure
Radiological dose in microsieverts as measured by dosimeters worn by operating room staff
Measured: At the time of discharge to the ward after surgery on Day 0
Number of participants with adverse events
Patients will be followed-up until Visit 3, 2-14 days after the end of surgery on Day 0 for adverse events
Measured: Visit 3, at day 3-15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Primary completion1 Jan 2016
Why it stopped: Technology licensed to third party. Sponsor did not proceed with study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lightpoint Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Semmelweis University
- Responsible party
- Sponsor
- Investigators
- Sheryl O'Farrell, PhD, Study director, Head of Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446379
- Sponsor's protocol ID
- LPM-005
- Acronym
- CLIO
- Status last verified
- Jan 2017
- First submitted
- 27 Apr 2015
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Intra-operative Molecular Imaging With BetaScope and in Vitro Measurement With LightPath Specimen Analyser Devices in Gastrointestinal Tumour Surgery
- ClinicalTrials.gov ID
- NCT02446379
- Acronym / sponsor ID
- CLIO / LPM-005
- Conditions
- Gastric Cancer, Pancreatic Cancer, Bile Duct Cancer, Duodenal Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Technology licensed to third party. Sponsor did not proceed with study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lightpoint Medical LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Semmelweis University
- Primary completion
- 1 Jan 2016 (actual)
- First posted
- 18 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EnLightTM and LightPathTM Imaging Systems arm | – | Drug: The marketed product 2-5 MBq/kg 18F-fluorodeoxyglucose, Device: EnLightTM, Device: LightPathTM Imaging SystemPatients 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). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female or male patients aged ≥ 30 years diagnosed with gastric, pancreatic, bile duct or duodenal cancer, whose treatment is to be tumour excision surgery.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The marketed product 2-5 MBq/kg 18F-fluorodeoxyglucoseAlso: FDGThe FDG is injected at least 120 minutes prior to the imaging by the EnLightTM and LightPathTM Imaging Systems | Drug | EnLightTM and LightPathTM Imaging Systems arm |
| EnLightTMThe surgical cavity and the resected lymph nodes (if any) will be imaged by the EnLightTM system to establish whether radioactive tissue remains after surgery. | Device | EnLightTM and LightPathTM Imaging Systems arm |
| LightPathTM Imaging SystemThe 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. | Device | EnLightTM and LightPathTM Imaging Systems arm |
Primary outcome
The location of PET imaging agent as measured by beta particle detection
Time frame: Intraoperatively (during the single session of surgery on Day 0)
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.
The location of PET imaging agent as measured by the LightPathTM Imaging System
Time frame: Intraoperatively (during the single session of surgery on Day 0)
The LightPathTM Imaging System will be used for determining the margin status of lesions and the metastatic involvement of lymph nodes.
6 secondary outcomes
The number of lesions by histopathology
Time frame: Expected on average Day 10 after surgery
The number of metastatic lymph nodes by histopathology
Time frame: Expected on average Day 10 after surgery
The extent of resection margins by histopathology
Time frame: Expected on average Day 10 after surgery
Ease of use measured by questionnaire
Time frame: At the end of imaging on Day 0
Radiation exposure
Time frame: At the time of discharge to the ward after surgery on Day 0
Number of participants with adverse events
Time frame: Visit 3, at day 3-15
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Sponsor company's clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheryl O'Farrell, PhD study director
Head of Clinical Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Pancreatic Cancer, run by Lightpoint Medical Limited at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The location of PET imaging agent as measured by beta particle detection (time frame: Intraoperatively (during the single session of surgery on Day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.