Near-infrared Imaging With Indocyanine Green for Detection of Peritoneal Metastases for Gastric Adenocarcinoma.

Phase 2

Terminated

• Conditions: Gastric Adenocarcinoma; Peritoneal Carcinomatosis; Peritoneal Metastases; Gastric Cancer
• Interventions: Drug: Indocyanine green

• Registration Number: NCT05687617
• Lead Sponsor: Laval University

Brief Summary

Peritoneal disease at initial presentation for patients with gastric adenocarcinoma (GA) is frequent, with 15-31% of patients presenting with peritoneal metastases (PM) at surgical exploration. The prognosis of patients with PM is poor, overall survival (OS) ranging from 8 to 13 months, reinforcing the importance of optimal patient selection before surgical management of GA.

Indocyanine Green (ICG) fluorescence imaging for intraoperative detection of PM has been described in recent literature as a useful tool in patients undergoing cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) for peritoneal malignancies to increase the detection of PM during surgery. However, the role of ICG for patients with GA, and its role during diagnosic laparoscopy (DL), remain unknown.

Detailed Description

This is a multicentric, prospective study . Patients will be referred to one of seven surgeons specialized in the surgical management of gastric cancer. Patients will undergo DL, with intravenous (IV) injection of 0.25 mg/kg of free ICG at the start of the surgery. DL will be first performed without fluorescence imaging in the standard fashion, with identification of potential PM. A first peritoneal cancer index (PCI) score will be calculated. Fluorescence imaging will then be performed, and correlation with previously identified lesions will be assessed and a second PCI score (with ICG) will be calculated. Biopsies will be performed to confirm the metastatic status of the lesions. Any suspicion for additional lesions visualized only under fluorescence imaging will be biopsied as well. Peritoneal fluid cytology will be performed at the beginning of the surgery.

Study Timeline

• Study Start: 2022-12-15
• Study First Submitted: 2023-01-08
• Study First Submitted QC: 2023-01-08
• Study First Posted: 2023-01-18
• Status Verified: 2024-03
• Primary Completion: 2024-03-27
• Study Completion: 2024-03-27
• Last Update Submitted: 2024-03-30
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Confirmed diagnosis of gastric adenocarcinoma.
• Clinical stage cT2 or higher.
• No evidence of metastatic disease on preoperative imaging.
• Patient fit for surgery (ECOG 0 or 1).

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Exclusion Criteria

• Indocyanine allergy.
• Gastric cancer subtype other than gastric adenocarcinoma.
• Unconfirmed diagnosis of gastric adenocarcinoma (unable to confirm diagnosis).
• Clinical stage cT1b or lower.
• Evidence of metastatic disease on preoperative imaging.
• Patient unfit for surgery (ECOG 2 or more).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gastric cancer with ICG	Indocyanine green	Patient to receive IV ICG during diagnostic laparoscopy.

Primary Outcome Measures

Name	Time	Method
Number of patients with additional lesions detected with ICG.	18 months	Patients with peritoneal metastases, in whom additional lesions are detected with ICG.
Number of patients with peritoneal metastases detected only with ICG.	18 months	Patients with peritoneal metastases, in whom lesions are detected only with ICG and diagnostic laparoscopy would be negative otherwise.

Trial Locations

Locations (2)

CIUSSS de l'Est-de-l'Île-de-Montréal; 🇨🇦 Montréal, Quebec, Canada

CHU de Québec; 🇨🇦 Quebec City, Quebec, Canada