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

• Status: Recruiting
• Trial end date: 2024-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laval University
• Collaborator: Ciusss de L'Est de l'Île de Montréal

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).