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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04761172

Enrollment

Registered

2021-02-18

Start date

2020-06-17

Completion date

2022-06-01

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GIST

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.

Interventions

PROCEDUREIntraoperative 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Open-label pilot study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Contacts

Primary ContactG. M. Kalisvaart, MD

g.m.kalisvaart@lumc.nl0715263695

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026