Intraoperative ICG Fluorescence Imaging for Peritoneal Carcinomatosis Detection

Overview

Background. Peritoneal carcinomatosis is a frequent and deadly localization of gastric cancer. Available imaging techniques have a low accuracy in detecting small peritoneal nodules, and direct laparoscopic visualization may fail too. A more accurate staging technique would be advantageous for individualization of therapeutic path. Indocyanine Green (ICG) fluorescence imaging has been reported as a tool for visualizing small peritoneal seedings due to the "enhanced permeability and retention" (EPR) effect of cancer nodules.

Aim. To explore the feasibility and effectiveness of fluorescence-enhanced peritoneal carcinomatosis detection in patients with gastric cancer undergoing staging laparoscopy.

Methods. This prospective, multicentric, single arm study will include patients with gastric cancer, without a radiological suspicion of peritoneal carcinomatosis, undergoing staging laparoscopy. An intravenous injection of ICG is given at different dosage and at different timepoints before the intervention. During the staging laparoscopy, the abdominal cavity exploration is performed using standard white-light, and subsequently using fluorescence imaging. Suspicious nodules are harvested, until a maximum of 5 per patient, and sent for definitive histological examination. Peritoneal washing is also harvested for cytologic assessment in all cases. The eventual benefit of fluorescence imaging in terms of additional peritoneal lesions that were not detected during standard white-light imaging is evaluated.

Discussion. This study will establish if fluorescence imaging increases sensitivity and/or specificity of staging laparoscopy in detecting peritoneal carcinomatosis from gastric cancer. Improved accuracy may translate in better care path selection.

Full Title of Study: “Indocyanine Green Fluorescence Detection of Peritoneal Carcinomatosis During Staging Laparoscopy for Gastric Cancer: Protocol for a Prospective Multicentric Single Arm Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2021

Interventions

  • Diagnostic Test: Fluorescence guided peritoneal exploration
    • Intravenous injection of ICG

Arms, Groups and Cohorts

  • Experimental: fluorescence guided peritoneal exploration
    • Indocyanine green (ICG) intravenous injection and peritoneal exploration with technology able to detect fluorescence generated by ICG

Clinical Trial Outcome Measures

Primary Measures

  • Best modality of ICG injection
    • Time Frame: intra-operative assessment
    • best timing of injection

Secondary Measures

  • Sensitivity of ICG fluorescence
    • Time Frame: intra-operative assessment
    • As compared with white light

Participating in This Clinical Trial

Inclusion Criteria

1. Age of ≥18years

2. Ability to provide written informed consent

3. Histologically confirmed gastric adenocarcinoma or oesophago-gastric junction adenocarcinoma Siewert 2 and 3

4. cT>1

5. cM0 (clinical staging: no metastases)

6. Staging laparoscopy is indicated by the internal work-up protocol

7. Staging laparoscopy is in accordance with NCCN (National Comprehensive Cancer Network) guidelines

Exclusion Criteria

1. Pregnancy

2. Iodine allergy/sensibility

3. Clinical P1 (defined as high probability of peritoneal carcinomatosis at imaging)

4. Investigator judgement that the patient should not participate for any reason

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gian Luca Baiocchi, Associate Professor – Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
  • Overall Official(s)
    • Gian Luca Baiocchi, Prof, Principal Investigator, ASST Spedali Civili, University of Brescia
  • Overall Contact(s)
    • Gian Luca Baiocchi, Prof., ++39 338 5949921, gianluca.baiocchi@unibs.it

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