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

NCT05687617 | Terminated Phase 2

• 1 other identifier: MP-20-2023-6524
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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.

Conditions

Gastric Cancer; Gastric Adenocarcinoma; Peritoneal Carcinomatosis; Peritoneal Metastases

Keywords

Diagnostic laparoscopy; ICG

Outcome Measures

Primary Outcomes (2)

• Number of patients with additional lesions detected with ICG.

  Patients with peritoneal metastases, in whom additional lesions are detected with ICG.

  18 months

• Number of patients with peritoneal metastases detected only with ICG.

  Patients with peritoneal metastases, in whom lesions are detected only with ICG and diagnostic laparoscopy would be negative otherwise.

  18 months

Study Arms (1)

Gastric cancer with ICG

EXPERIMENTAL

Patient to receive IV ICG during diagnostic laparoscopy.

Drug: Indocyanine green

Interventions

Indocyanine green DRUG

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

Also known as: ICG

Gastric cancer with ICG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Laval University: lead
• Ciusss de L'Est de l'Île de Montréal: collaborator

Study Sites (2)

CIUSSS de l'Est-de-l'Île-de-Montréal

Montreal, Quebec, H1T 2M4, Canada

Location

CHU de Québec

Québec, Quebec, G1R 2J6, Canada

Location

Related Publications (18)

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MeSH Terms

Conditions

Stomach Neoplasms; Peritoneal Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Abdominal Neoplasms; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Alexandre Brind'Amour, MD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: January 18, 2023
• Study Start: December 15, 2022
• Primary Completion: March 27, 2024
• Study Completion: March 27, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)