Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05687617
Status:
TERMINATED
Last Update Posted:
2024-04-02
First Post:
2023-01-08
Brief Title:
Near-infrared Imaging With Indocyanine Green for Detection of Peritoneal Metastases for Gastric Adenocarcinoma
Sponsor:
Laval University
Organization:
Laval University
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment lower than expected and negative results
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 025 mgkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None