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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative near-infrared fluorescence imaging using indocyaninegreen | Procedure | ICG administration before/during surgery and using near-infrared fluorescence imaging for intra-operative detection and identification of GISTs |
| Measure | Description | Time Frame |
|---|---|---|
| Primary tumor detection | Tumor detection perceived by the surgeon with and without NIR-imaging | Intra-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of peritoneal tumor depositions | Detection of peritoneal tumor depositions by the surgeon with and without NIR-imaging | Intra-operative |
| Tumor to background ratio | Pixel intensity ratio on static images |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| G. M. Kalisvaart, MD | Contact | 0715263695 | g.m.kalisvaart@lumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| J. A. van der Hage | Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Recruiting | Leiden | Netherlands |
On request anonymized data can be shared with other researchers
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Open-label pilot study
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| Through study completion, estimated to be 6 months |
| Erasmus Medical Center | Recruiting | Rotterdam | Netherlands |
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