Clincosm LogoSign in Get a demo

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

Sponsor
Laval University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05687617
Collaborator
Ciusss de L'Est de l'Île de Montréal (Other)
30
Enrollment
2
Locations
1
Arm
24
Anticipated Duration (Months)
15
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Indocyanine green
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Diagnostic Value of Intraoperative Near-infrared Imaging With Indocyanine Green for Detection of Peritoneal Metastases During Staging Laparoscopy for Gastric Adenocarcinoma: a Prospective, Multicentric Study.
Actual Study Start Date :
Dec 15, 2022
Anticipated Primary Completion Date :
Jun 15, 2024
Anticipated Study Completion Date :
Dec 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gastric cancer with ICG

Patient to receive IV ICG during diagnostic laparoscopy.

Drug: Indocyanine green
0,25mg/kg IV at the start of the surgery,
Other Names:
  • ICG

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with additional lesions detected with ICG. [18 months]

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

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CIUSSS de l'Est-de-l'Île-de-Montréal Montréal Quebec Canada H1T 2M4
    2 CHU de Québec Quebec City Quebec Canada G1R 2J6

    Sponsors and Collaborators

    • Laval University
    • Ciusss de L'Est de l'Île de Montréal

    Investigators

    • Principal Investigator: Alexandre Brind'Amour, MD, Laval University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Alexandre Brind'Amour, Doctor, Laval University
    ClinicalTrials.gov Identifier:
    NCT05687617
    Other Study ID Numbers:
    • MP-20-2023-6524
    First Posted:
    Jan 18, 2023
    Last Update Posted:
    Jan 18, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Alexandre Brind'Amour, Doctor, Laval University
    Diagnostic laparoscopy
    ICG
    Additional relevant MeSH terms:
    Adenocarcinoma
    Neoplasm Metastasis
    Carcinoma
    Peritoneal Neoplasms

    Study Results

    No Results Posted as of Jan 18, 2023