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Clinical Trials/NCT04761172
NCT04761172UnknownPhase 2

Near-infrared Fluorescence Imaging With IndoCyanine Green for the Intraoperative Identification of Gastrointestinal Stromal Cell Tumours: a Pilot Study

Leiden University Medical Center2 sites in 1 country10 target enrollmentStarted: June 17, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Sponsor
Enrollment
10
Locations
2
Primary Endpoint
Primary tumor detection
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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), 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients diagnosed with GIST by histology or cytology, localized or metastasized, scheduled to undergo an elective open or laparoscopic resection.

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)

Outcomes

Primary Outcomes

Primary tumor detection

Time Frame: Intra-operative

Tumor detection perceived by the surgeon with and without NIR-imaging

Secondary Outcomes

  • Tumor to background ratio(Through study completion, estimated to be 6 months)
  • Detection of peritoneal tumor depositions(Intra-operative)

Investigators

Sponsor
Leiden University Medical Center
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

javanderhage

Prof. dr.

Leiden University Medical Center

Study Sites (2)

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