Clinical trial · Observational
Use of the EnLightTM and LightPathTM Imaging Systems in Gastrointestinal Tumour Surgery
Evaluation of the Use of Intra-operative Molecular Imaging With BetaScope and in Vitro Measurement With LightPath Specimen Analyser Devices in Gastrointestinal Tumour Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Technology licensed to third party. Sponsor did not proceed with study.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Duodenal Cancer | Malignant Duodenal Neoplasm | ALIAS | 0.90 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EnLightTM | Device | — | UNRESOLVED |
| LightPathTM Imaging System | Device | — | UNRESOLVED |
| The marketed product 2-5 MBq/kg 18F-fluorodeoxyglucose | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- EnLightTM and LightPathTM Imaging Systems arm
- description
- 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).
- interventionNames
- Drug: The marketed product 2-5 MBq/kg 18F-fluorodeoxyglucose
- Device: EnLightTM
- Device: LightPathTM Imaging System
Primary outcomes (2)
- measure
- The location of PET imaging agent as measured by beta particle detection
- timeFrame
- Intraoperatively (during the single session of surgery on Day 0)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available