NCT04761172

NIR Fluorescence Imaging With ICG for the Intraoperative Identification of Gastrointestinal Stromal Cell Tumours

Near-infrared Fluorescence Imaging With IndoCyanine Green for the Intraoperative Identification of Gastrointestinal Stromal Cell Tumours: a Pilot Study

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label pilot study including 10 GIST patients scheduled for an elective open or laparoscopic resection at Leiden University Medical Center (LUMC) and Erasmus Medical Center (EMC), Rotterdam. Patients will receive a single dose injection of 10mg ICG at a given moment during the 24 hours prior to surgery or during surgery. The timing of administration will be determined according to a step-up, step-down procedure. Standard of care surgery will be performed and a NIR fluorescence imaging system will be used to record the GIST under fluorescence.

Conditions

• GIST

Interventions

Type	Name	Description
PROCEDURE	Intraoperative near-infrared fluorescence imaging using indocyaninegreen	ICG administration before/during surgery and using near-infrared fluorescence imaging for intra-operative detection and identification of GISTs

Timeline

• Start date: 2020-06-17
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2021-02-18
• Last updated: 2021-02-18

Locations

2 sites across 1 country: Netherlands