Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GIST | Gastrointestinal Stromal Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative near-infrared fluorescence imaging using indocyaninegreen | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Primary tumor detection
- timeFrame
- Intra-operative
- description
- Tumor detection perceived by the surgeon with and without NIR-imaging
Secondary outcomes (2)
- measure
- Detection of peritoneal tumor depositions
- timeFrame
- Intra-operative
- description
- Detection of peritoneal tumor depositions by the surgeon with and without NIR-imaging
- measure
- Tumor to background ratio
- timeFrame
- Through study completion, estimated to be 6 months
- description
- Pixel intensity ratio on static images
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available