Intraoperative ICG Fluorescence Imaging for Peritoneal Carcinomatosis Detection

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

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.

Study Overview

• Status: Unknown
• Conditions: Gastric Cancer; Peritoneal Carcinomatosis
• Intervention / Treatment: Diagnostic test: Fluorescence guided peritoneal exploration

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age of ≥18years
2. Ability to provide written informed consent
3. Histologically confirmed gastric adenocarcinoma or oesophago-gastric junction adenocarcinoma Siewert 2 and 3
4. cT>1
5. cM0 (clinical staging: no metastases)
6. Staging laparoscopy is indicated by the internal work-up protocol
7. Staging laparoscopy is in accordance with NCCN (National Comprehensive Cancer Network) guidelines

Exclusion Criteria:

1. Pregnancy
2. Iodine allergy/sensibility
3. Clinical P1 (defined as high probability of peritoneal carcinomatosis at imaging)
4. Investigator judgement that the patient should not participate for any reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: fluorescence guided peritoneal exploration; Indocyanine green (ICG) intravenous injection and peritoneal exploration with technology able to detect fluorescence generated by ICG	Diagnostic test: Fluorescence guided peritoneal exploration; Intravenous injection of ICG

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Investigators: Principal Investigator: Gian Luca Baiocchi, Prof, ASST Spedali Civili, University of Brescia

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (ACTUAL): April 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2020
• Last Update Submitted That Met QC Criteria: April 17, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Abdominal Neoplasms; Stomach Neoplasms; Carcinoma; Peritoneal Neoplasms
• Other Study ID Numbers: AOBrescia_baiocchi_ICG1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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