Near-infrared Imaging With Indocyanine Green for Detection of Peritoneal Metastases for Gastric Adenocarcinoma.
Primary Purpose
Gastric Cancer, Gastric Adenocarcinoma, Peritoneal Carcinomatosis
Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Indocyanine green
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastric Cancer focused on measuring Diagnostic laparoscopy, ICG
Eligibility 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).
Sites / Locations
- CIUSSS de l'Est-de-l'Île-de-MontréalRecruiting
- CHU de QuébecRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gastric cancer with ICG
Arm Description
Patient to receive IV ICG during diagnostic laparoscopy.
Outcomes
Primary Outcome Measures
Number of patients with additional lesions detected with ICG.
Patients with peritoneal metastases, in whom additional lesions are detected with ICG.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05687617
First Posted
January 8, 2023
Last Updated
January 8, 2023
Sponsor
Laval University
Collaborators
Ciusss de L'Est de l'Île de Montréal
1. Study Identification
Unique Protocol Identification Number
NCT05687617
Brief Title
Near-infrared Imaging With Indocyanine Green for Detection of Peritoneal Metastases for Gastric Adenocarcinoma.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Ciusss de L'Est de l'Île de Montréal
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastric Adenocarcinoma, Peritoneal Carcinomatosis, Peritoneal Metastases
Keywords
Diagnostic laparoscopy, ICG
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gastric cancer with ICG
Arm Type
Experimental
Arm Description
Patient to receive IV ICG during diagnostic laparoscopy.
Intervention Type
Drug
Intervention Name(s)
Indocyanine green
Other Intervention Name(s)
ICG
Intervention Description
0,25mg/kg IV at the start of the surgery,
Primary Outcome Measure Information:
Title
Number of patients with additional lesions detected with ICG.
Description
Patients with peritoneal metastases, in whom additional lesions are detected with ICG.
Time Frame
18 months
Title
Number of patients with peritoneal metastases detected only with ICG.
Description
Patients with peritoneal metastases, in whom lesions are detected only with ICG and diagnostic laparoscopy would be negative otherwise.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Brind'Amour, MD
Phone
4185254444
Ext
15925
Email
godonco@chudequebec.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Brind'Amour, MD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CIUSSS de l'Est-de-l'Île-de-Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mai-Kim Gervais, MD
Phone
+14182523400
Ext
5766
First Name & Middle Initial & Last Name & Degree
Pierre Dubé, MD
First Name & Middle Initial & Last Name & Degree
Lucas Sidéris, MD
First Name & Middle Initial & Last Name & Degree
Jean-François Tremblay, MD
First Name & Middle Initial & Last Name & Degree
Mikaël L. Soucisse, MD
Facility Name
CHU de Québec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Brind'Amour
Phone
+14185254444
Ext
15925
Email
godonco@chudequebec.ca
First Name & Middle Initial & Last Name & Degree
Cindy Boulanger-Gobeil, MD
First Name & Middle Initial & Last Name & Degree
Philippe Bouchard, MD
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Gagné, MD
First Name & Middle Initial & Last Name & Degree
Éric Poirier, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Learn more about this trial
Near-infrared Imaging With Indocyanine Green for Detection of Peritoneal Metastases for Gastric Adenocarcinoma.
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