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

• Sponsor: Leiden University Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04761172
• Collaborator: (none)
• Enrollment: 10
• Locations: 2
• Anticipated Duration (Months): 23.5
• Patients Per Site: 5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
GIST	Procedure: Intraoperative near-infrared fluorescence imaging using indocyaninegreen	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Open-label pilot studyOpen-label pilot study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Near-infrared Fluorescence Imaging With IndoCyanine Green for the Intraoperative Identification of Gastrointestinal Stromal Cell Tumours: a Pilot Study
• Actual Study Start Date: Jun 17, 2020
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Jun 1, 2022

Outcome Measures

Primary Outcome Measures

1. Primary tumor detection [Intra-operative]

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

Secondary Outcome Measures

1. Detection of peritoneal tumor depositions [Intra-operative]

   Detection of peritoneal tumor depositions by the surgeon with and without NIR-imaging

2. Tumor to background ratio [Through study completion, estimated to be 6 months]

   Pixel intensity ratio on static images

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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.

• 18 years

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leiden University Medical Center	Leiden		Netherlands
2	Erasmus Medical Center	Rotterdam		Netherlands

Sponsors and Collaborators

• Leiden University Medical Center

Investigators

• Principal Investigator: J. A. van der Hage, Leiden University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: javanderhage, Prof. dr., Leiden University Medical Center
• ClinicalTrials.gov Identifier: NCT04761172
• Other Study ID Numbers: NL67828.058.18
• First Posted: Feb 18, 2021
• Last Update Posted: Feb 18, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Feb 18, 2021