Fluorescence with ICG in GIST resections: a pilot study

Phase 1

• Conditions: GIST Gastrointestinal stromal cell tumour; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2019-003119-77-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-24
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Patients diagnosed with GIST by histology, localized or metastasized, scheduled to undergo an elective open or laparoscopic resection.
>18 years

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified