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

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.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05687617

Enrollment

Registered

2023-01-18

Start date

2022-12-15

Completion date

2024-03-27

Last updated

2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Adenocarcinoma, Gastric Cancer, Peritoneal Carcinomatosis, Peritoneal Metastases

Keywords

Diagnostic laparoscopy, ICG

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.

Interventions

DRUGIndocyanine green

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026