NIR Fluorescence Imaging With ICG for the Intraoperative Identification of Gastrointestinal Stromal Cell Tumours

Last updated: February 17, 2021
Sponsor: Leiden University Medical Center
Overall Status: Active - Recruiting

Phase

2/3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04761172
NL67828.058.18
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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)

Study Design

Total Participants: 10
Study Start date:
June 17, 2020
Estimated Completion Date:
June 01, 2022

Connect with a study center

  • Leiden University Medical Center

    Leiden,
    Netherlands

    Active - Recruiting

  • Erasmus Medical Center

    Rotterdam,
    Netherlands

    Active - Recruiting

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