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

NCT ID: NCT05687617

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2024-03-27

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.

Conditions

Gastric Cancer; Gastric Adenocarcinoma; Peritoneal Carcinomatosis; Peritoneal Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Gastric cancer with ICG

Patient to receive IV ICG during diagnostic laparoscopy.

Group Type: EXPERIMENTAL

Indocyanine green

Intervention Type: DRUG

0,25mg/kg IV at the start of the surgery,

Interventions

Indocyanine green

0,25mg/kg IV at the start of the surgery,

Intervention Type: DRUG

Other Intervention Names

ICG

Eligibility Criteria

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).

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ciusss de L'Est de l'Île de Montréal

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Alexandre Brind'Amour

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandre Brind'Amour, MD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

CIUSSS de l'Est-de-l'Île-de-Montréal

Montreal, Quebec, Canada

CHU de Québec

Québec, Quebec, Canada

Countries

Canada

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Other Identifiers

MP-20-2023-6524

Identifier Type: -

Identifier Source: org_study_id