Fluorescence with ICG in GIST resections: a pilot study

Near-infrared fluorescence imaging with IndoCyanine Green for the intraoperative identification of Gastrointestinal stromal cell tumours: a pilot study

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003119-77-NL

Enrollment

Registered

2020-02-24

Start date

2020-02-24

Completion date

Unknown

Last updated

2020-07-06

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

Conditions

GIST Gastrointestinal stromal cell tumour

Interventions

Trade Name: VERDYE 25 mg / VERDYE 50 mg Pharmaceutical Form: Powder for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients diagnosed with GIST by histology, localized or metastasized, scheduled to undergo an elective open or laparoscopic resection. >18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

Exclusion criteria

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
Main Objective: Primary objective: to assess the diagnostic value of ICG in intraoperative GIST and GIST metastasis detection ;Secondary Objective: Secondary objective: tumor to background ratio will be determined, which is defined as the fluorescence signal in the tumor compared to the fluorescence signal of the surrounding tissue;Primary end point(s): percentage of patients in whom during surgery the GIST or metastases can be identified with ICG and NIR. The signal in tumour tissue compared to the signal of the surrounding tissue, i.e. tumour-to-backgroundratio (TBR) will be calculated. Furthermore, number of tumor depositions only visible for the surgeon with NIR imaging will be registered;Timepoint(s) of evaluation of this end point: During/Directly after surgery	—

Measure

Time frame

Main Objective: Primary objective: to assess the diagnostic value of ICG in intraoperative GIST and GIST metastasis detection ;Secondary Objective: Secondary objective: tumor to background ratio will be determined, which is defined as the fluorescence signal in the tumor compared to the fluorescence signal of the surrounding tissue;Primary end point(s): percentage of patients in whom during surgery the GIST or metastases can be identified with ICG and NIR. The signal in tumour tissue compared to the signal of the surrounding tissue, i.e. tumour-to-backgroundratio (TBR) will be calculated. Furthermore, number of tumor depositions only visible for the surgeon with NIR imaging will be registered;Timepoint(s) of evaluation of this end point: During/Directly after surgery

—

Secondary

Measure	Time frame
Secondary end point(s): The signal in tumour tissue compared to the signal of the surrounding tissue, i.e. tumour-to-backgroundratio (TBR) will be calculated. Furthermore, number of tumor depositions only visible for the surgeon with NIR imaging will be registered;Timepoint(s) of evaluation of this end point: During/Directly after surgery	—

Countries

Netherlands

Contacts

Public ContactJos van der Hage

Leiden University Medical Center

j.a.van_der_hage@lumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026