Status:
UNKNOWN
NIR Fluorescence Imaging With ICG for the Intraoperative Identification of Gastrointestinal Stromal Cell Tumours
Lead Sponsor:
Leiden University Medical Center
Conditions:
GIST
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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), Rotte...
Eligibility Criteria
Inclusion
- Patients diagnosed with GIST by histology or cytology, localized or metastasized, scheduled to undergo an elective open or laparoscopic resection.
- 18 years
Exclusion
- 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)
Key Trial Info
Start Date :
June 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04761172
Start Date
June 17 2020
End Date
June 1 2022
Last Update
February 18 2021
Active Locations (2)
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1
Leiden University Medical Center
Leiden, Netherlands
2
Erasmus Medical Center
Rotterdam, Netherlands