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

Leiden University Medical Center10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

GIST

Interventions

Intraoperative near-infrared fluorescence imaging using indocyaninegreen

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (2)

Leiden University Medical Center

Leiden, Netherlands

RECRUITING

Erasmus Medical Center

Rotterdam, Netherlands

RECRUITING

Outcomes

Primary Outcomes

Primary tumor detection

Tumor detection perceived by the surgeon with and without NIR-imaging

Time frame: Intra-operative

Secondary Outcomes

Detection of peritoneal tumor depositions

Detection of peritoneal tumor depositions by the surgeon with and without NIR-imaging