Pancreatic Cancer Clinical Trial
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.
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.
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