Intraoperative ICG Fluorescence Imaging for Peritoneal Carcinomatosis Detection

Study Overview
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Brief Summary
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Background. Peritoneal carcinomatosis is a frequent and deadly localization of gastric cancer. Available imaging techniques have a low accuracy in detecting small peritoneal nodules, and direct laparoscopic visualization may fail too. A more accurate staging technique would be advantageous for individualization of therapeutic path. Indocyanine Green (ICG) fluorescence imaging has been reported as a tool for visualizing small peritoneal seedings due to the enhanced permeability and retention (EPR) effect of cancer nodules. Aim. To explore the feasibility and effectiveness of fluorescence-enhanced peritoneal carcinomatosis detection in patients with gastric cancer undergoing staging laparoscopy. Methods. This prospective, multicentric, single arm study will include patients with gastric cancer, without a radiological suspicion of peritoneal carcinomatosis, undergoing staging laparoscopy. An intravenous injection of ICG is given at different dosage and at different timepoints before the intervention. During the staging laparoscopy, the abdominal cavity exploration is performed using standard white-light, and subsequently using fluorescence imaging. Suspicious nodules are harvested, until a maximum of 5 per patient, and sent for definitive histological examination. Peritoneal washing is also harvested for cytologic assessment in all cases. The eventual benefit of fluorescence imaging in terms of additional peritoneal lesions that were not detected during standard white-light imaging is evaluated. Discussion. This study will establish if fluorescence imaging increases sensitivity and/or specificity of staging laparoscopy in detecting peritoneal carcinomatosis from gastric cancer. Improved accuracy may translate in better care path selection.

Official Title
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Indocyanine Green Fluorescence Detection of Peritoneal Carcinomatosis During Staging Laparoscopy for Gastric Cancer: Protocol for a Prospective Multicentric Single Arm Study

Conditions
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Peritoneal Carcinomatosis, Gastric Cancer

Intervention / Treatment
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* Diagnostic Test: Fluorescence guided peritoneal exploration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of ≥18years Ability to provide written informed consent Histologically confirmed gastric adenocarcinoma or oesophago-gastric junction adenocarcinoma Siewert 2 and 3 cT>1 cM0 (clinical staging: no metastases) Staging laparoscopy is indicated by the internal work-up protocol Staging laparoscopy is in accordance with NCCN (National Comprehensive Cancer Network) guidelines Exclusion Criteria: Pregnancy Iodine allergy/sensibility Clinical P1 (defined as high probability of peritoneal carcinomatosis at imaging) Investigator judgement that the patient should not participate for any reason

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fluorescence guided peritoneal exploration<br>Indocyanine green (ICG) intravenous injection and peritoneal exploration with technology able to detect fluorescence generated by ICG | Diagnostic Test: Fluorescence guided peritoneal exploration<br>* Intravenous injection of ICG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best modality of ICG injection | best timing of injection | intra-operative assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of ICG fluorescence | As compared with white light | intra-operative assessment |