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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lightpoint Medical Limited
• Collaborator: Semmelweis University
• Treatments: Deoxyglucose; Fluorodeoxyglucose F18

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.