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

NCT04761172 | Unknown Phase 2

• 1 other identifier: NL67828.058.18
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

GIST

Outcome Measures

Primary Outcomes (1)

• Primary tumor detection

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

  Intra-operative

Secondary Outcomes (2)

• Detection of peritoneal tumor depositions

  Intra-operative

• Tumor to background ratio

  Through study completion, estimated to be 6 months

Interventions

Intraoperative near-infrared fluorescence imaging using indocyaninegreen PROCEDURE

ICG administration before/during surgery and using near-infrared fluorescence imaging for intra-operative detection and identification of GISTs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (2)

Leiden University Medical Center

Leiden, Netherlands

RECRUITING

Erasmus Medical Center

Rotterdam, Netherlands

RECRUITING

Study Officials

• J. A. van der Hage

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

G. M. Kalisvaart, MD

CONTACT

0715263695; g.m.kalisvaart@lumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Model Details: Open-label pilot study

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: February 18, 2021
• Study Start: June 17, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)