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

Leiden University Medical Center (LUMC)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: GIST

Treatments: Procedure: Intraoperative near-infrared fluorescence imaging using indocyaninegreen

Study type: Interventional

Funder types: Other

Identifiers

NCT04761172

NL67828.058.18

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)