MedTrace Logo

Use of the EnLightTM and LightPathTM Imaging Systems in Gastrointestinal Tumour Surgery

NCT02446379 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2017-01-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

The marketed product 2-5 MBq/kg 18F-fluorodeoxyglucose

The FDG is injected at least 120 minutes prior to the imaging by the EnLightTM and LightPathTM Imaging Systems

DEVICE

EnLightTM

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.

DEVICE

LightPathTM Imaging System

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.

Sponsors & Collaborators

  • Semmelweis University

    collaborator OTHER

  • Lightpoint Medical Limited

    lead INDUSTRY

Principal Investigators

  • Sheryl O'Farrell, PhD · Head of Clinical Development

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2016-01-01

Countries

  • Hungary

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02446379 on ClinicalTrials.gov