NCT04943484 ICG (Indocyanine Green) Imaging Fluorescence Technology in Surgical Treatment of Advanced Gastric Cancer
| NCT ID | NCT04943484 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Niguarda Hospital |
| Condition | Gastric Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 360 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2024-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 360 participants in total. It began in 2022-01-01 with a primary completion date of 2024-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The iGreenGO Study aims to investigate whether the intraoperative application of NIR/ICG technology is associated with a change in the surgical conduct (CSC) during curative-intent gastrectomy with D2 lymphadenectomy in a cohort of Western patients affected by AGC. The preoperative clinical variables potentially associated with CSC will be also investigated
Eligibility Criteria
Inclusion criteria * Age ≥ 18 years old * Preoperative histologically proven adenocarcinoma of the upper, middle or lower part of the stomach. * Advanced disease (Staged cT2-T4a, N0-3;M0 according to 8th edition of the AJCC TNM Staging System) at diagnosis, in which resection can be safely achieved by distal or total gastrectomy with D2 lymphadenectomy via a minimally invasive (laparoscopic or robotic) approach, either as first treatment or after neoadjuvant treatment * No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative and intraoperative examinations * Written informed consent Exclusion criteria * Women during pregnancy or breast-feeding * History of previous upper abdominal surgery (laparoscopic cholecystectomy will be allowed) * History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection * History of allergy to iodine agents * Cancer located at the esophago-gastric junction (Siewert I, II, III tumors 29) * Patients candidates to transthoracic esophagectomy, transhiatal extended gastrectomy or proximal gastrectomy * History of previous neoadjuvant chemotherapy (except perioperative chemotherapy for gastric cancer) or radiotherapy
Contact & Investigator
Pietro M Lombardi, MD
PRINCIPAL INVESTIGATOR
Division of Minimally Invasive Surgical Oncology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda
Frequently Asked Questions
Who can join the NCT04943484 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04943484 currently recruiting?
Yes, NCT04943484 is actively recruiting participants. Contact the research team at pietrom.lombardi@gmail.com for enrollment information.
Where is the NCT04943484 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT04943484 clinical trial?
NCT04943484 is sponsored by Niguarda Hospital. The principal investigator is Pietro M Lombardi, MD at Division of Minimally Invasive Surgical Oncology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda. The trial plans to enroll 360 participants.
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