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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
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
|
Intravenous injection of ICG
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Best modality of ICG injection
Time Frame: intra-operative assessment
|
best timing of injection
|
intra-operative assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity of ICG fluorescence
Time Frame: intra-operative assessment
|
As compared with white light
|
intra-operative assessment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gian Luca Baiocchi, Prof, ASST Spedali Civili, University of Brescia
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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