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

GIST Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04761172
• Other study ID #: NL67828.058.18
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 17, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: February 2021
• Source: Leiden University Medical Center
• Contact: G. M. Kalisvaart, MD
• Phone: 0715263695
• Email: g.m.kalisvaart[@]lumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• GIST

Intervention

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

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary tumor detection	Tumor detection perceived by the surgeon with and without NIR-imaging	Intra-operative
Secondary	Detection of peritoneal tumor depositions	Detection of peritoneal tumor depositions by the surgeon with and without NIR-imaging	Intra-operative
Secondary	Tumor to background ratio	Pixel intensity ratio on static images	Through study completion, estimated to be 6 months