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Clinical Trials/EUCTR2019-003119-77-NL
EUCTR2019-003119-77-NL
Active, not recruiting
Phase 1

ear-infrared fluorescence imaging with IndoCyanine Green for the intraoperative identification of Gastrointestinal stromal cell tumours: a pilot study

eiden University Medical Center0 sites10 target enrollmentFebruary 24, 2020
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ConditionsGIST Gastrointestinal stromal cell tumourTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
DrugsVERDYE 25 mg / VERDYE 50 mg

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
GIST Gastrointestinal stromal cell tumour
Sponsor
eiden University Medical Center
Enrollment
10
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 24, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
eiden University Medical Center

Eligibility Criteria

Inclusion Criteria

  • •Patients diagnosed with GIST by histology, localized or metastasized, scheduled to undergo an elective open or laparoscopic resection.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 7
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 3

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

Not specified

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