Intraoperative ICG Fluorescence Imaging for Peritoneal Carcinomatosis Detection

NCT04352894 | Unknown

• 1 other identifier: AOBrescia_baiocchi_ICG1
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Peritoneal Carcinomatosis; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Best modality of ICG injection

  best timing of injection

  intra-operative assessment

Secondary Outcomes (1)

• Sensitivity of ICG fluorescence

  intra-operative assessment

Study Arms (1)

fluorescence guided peritoneal exploration

EXPERIMENTAL

Indocyanine green (ICG) intravenous injection and peritoneal exploration with technology able to detect fluorescence generated by ICG

Diagnostic Test: Fluorescence guided peritoneal exploration

Interventions

Fluorescence guided peritoneal exploration DIAGNOSTIC_TEST

Intravenous injection of ICG

fluorescence guided peritoneal exploration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

MeSH Terms

Conditions

Peritoneal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Gian Luca Baiocchi, Prof

  ASST Spedali Civili, University of Brescia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gian Luca Baiocchi, Prof.

CONTACT

++39 338 5949921; gianluca.baiocchi@unibs.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 20, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share