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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-17

Study Completion Date

2022-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Subjective Near-infrared Fluorescence Guidance in Perfusion Assessment of Ileal Pouch Formation and Ileal-pouch-anal Anastomosis

NCT04695184

Ulcerative Colitis Colorectal Cancer Crohn Disease +3 more

UNKNOWN NA

Application of Indocyanine Green Labeled Fluorescent Laparoscopy in Proximal Gastric Cancer

NCT05369117

Gastric Cancer

NOT_YET_RECRUITING NA

Detection of Upper Gastrointestinal Tumour Depth and Demarcation Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection

NCT07108855

Esophageal Carcinoma Gastric Carcinoma

RECRUITING PHASE1/PHASE2

Fluorescence Guided Minimally-Invasive Resection Of Abdominal Paragangliomas Using Indocyanine Green

NCT06155734

Paraganglioma

RECRUITING

Indocyanine Green Fluorescent Molecular Imaging of the Gastrointestinal Tract

NCT01112514

High Risk Polyposis Syndrome Distal Colonic Lesions Colorectal Polyps

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

GIST

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-label pilot study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intraoperative near-infrared fluorescence imaging using indocyaninegreen

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No