Clinical trial NCT02446379: Use of the EnLightTM and LightPathTM Imaging Systems in Gastrointestinal Tumour Surgery
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gastric Cancer
Pancreatic Cancer
Bile Duct Cancer
Duodenal Cancer
Lead sponsor: Lightpoint Medical Limited
Sponsor class: INDUSTRY
Collaborators: name: Semmelweis University
First posted: 2015-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Provides written informed consent to participate in the study.
2. Is a man or woman aged ≥ 30 years.
3. Patients diagnosed with gastric, pancreatic, bile duct or duodenal cancer whose treatment is to be tumour excision surgery.
4. Life expectancy of at least 12 months.
5. Blood glucose level \< 12 mmol/l.

Exclusion Criteria:

1. Participation in another clinical study either concurrently or within 180 days prior to surgery.
2. Major surgery within 30 days before the baseline visit.
3. Women who are pregnant or lactating.
4. Renal impairment, hepatic impairment, serious infection or other life-threatening illness, other than cancer, within 60 days before surgery.
5. Previous exposure to ionizing radiation \>5 millisieverts (mSv) in the previous 12 months.

Primary outcomes:
measure: The location of PET imaging agent as measured by beta particle detection
timeFrame: Intraoperatively (during the single session of surgery on Day 0)
measure: The location of PET imaging agent as measured by the LightPathTM Imaging System
timeFrame: Intraoperatively (during the single session of surgery on Day 0)
Secondary outcomes:
measure: The number of lesions by histopathology
timeFrame: Expected on average Day 10 after surgery
measure: The number of metastatic lymph nodes by histopathology
timeFrame: Expected on average Day 10 after surgery
measure: The extent of resection margins by histopathology
timeFrame: Expected on average Day 10 after surgery
measure: Ease of use measured by questionnaire
timeFrame: At the end of imaging on Day 0
measure: Radiation exposure
timeFrame: At the time of discharge to the ward after surgery on Day 0
measure: Number of participants with adverse events
timeFrame: Visit 3, at day 3-15
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University First Clinic of Surgery
Study officials:
affiliation: Head of Clinical Development
name: Sheryl O'Farrell, PhD
role: STUDY_DIRECTOR
References: