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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04352894
Enrollment
120
Registered
2020-04-20
Start date
2020-09-30
Completion date
2021-09-30
Last updated
2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Peritoneal Carcinomatosis

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.

Interventions

DIAGNOSTIC_TESTFluorescence guided peritoneal exploration

Intravenous injection of ICG

Sponsors

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Best modality of ICG injectionintra-operative assessmentbest timing of injection

Secondary

MeasureTime frameDescription
Sensitivity of ICG fluorescenceintra-operative assessmentAs compared with white light

Contacts

Primary ContactGian Luca Baiocchi, Prof.
gianluca.baiocchi@unibs.it++39 338 5949921

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026