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

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.

Study Overview

• Status: Unknown
• Conditions: GIST
• Intervention / Treatment: Procedure: Intraoperative near-infrared fluorescence imaging using indocyaninegreen

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Leiden, Netherlands
    • Recruiting
    • Leiden University Medical Center
    • Contact: G. M. Kalisvaart; Email: g.m.kalisvaart@lumc.nl
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus Medical Center
    • Contact: H. A. Galema

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary tumor detection	Tumor detection perceived by the surgeon with and without NIR-imaging	Intra-operative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Investigators: Principal Investigator: J. A. van der Hage, Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: NL67828.058.18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: On request anonymized data can be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No