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

Phase 2

• Conditions: GIST

• Registration Number: NCT04761172
• Lead Sponsor: Leiden University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-17
• Study First Submitted: 2021-01-11
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-17
• Last Update Submitted: 2021-02-17
• Study First Posted: 2021-02-18
• Last Update Posted: 2021-02-18
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients diagnosed with GIST by histology or cytology, localized or metastasized, scheduled to undergo an elective open or laparoscopic resection.
• 18 years

Exclusion Criteria

• History of an allergy or hypersensitivity to sodium iodide, iodine or ICG
• Patients with hyperthyroidism and patients with an autonomous thyroid adenoma
• Patients pregnant or breastfeeding
• Patients with severe renal insufficiency (eGFR <30)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary tumor detection	Intra-operative	Tumor detection perceived by the surgeon with and without NIR-imaging

Secondary Outcome Measures

Name	Time	Method
Tumor to background ratio	Through study completion, estimated to be 6 months	Pixel intensity ratio on static images
Detection of peritoneal tumor depositions	Intra-operative	Detection of peritoneal tumor depositions by the surgeon with and without NIR-imaging

Trial Locations

Locations (2)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands