Gastric CanceriGreenGONCT04943484
ICG (Indocyanine Green) Imaging Fluorescence Technology in Surgical Treatment of Advanced Gastric Cancer
An observational study of Gastric Cancer, run by Niguarda Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- imaging fluorescence NIR/ICG
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 360 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female subjects, over 18 years of age, with histological diagnosis of locally advanced gastric carcinoma (AGC), surgically resectable, without evidence of distant metastases (cT2-T4a; N0-3; M0) for which a surgical intervention with curative purposes is indicated both as a first treatment and following preoperative neoadjuvant chemotherapy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ASST GOM Niguarda
Milan, Italia, 20162
Pietro M Lombardi, MD, 0039026444 ext. 4570, pietrom.lombardi@gmail.com
About this study
Official title: [The iGreenGO Study]. Investigation About the Clinical Value of Indocyanine Green Imaging Fluorescence (NIR/ICG) Technology as a Modifier of Surgeon's Conduct During Curative Treatment of Advanced Gastric Cancer. Study Protocol for a Western, Observational, Prospective, Multicentric Study
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
Read the detailed description
Near infra-red/ indocyanine green imaging fluorescence (NIR/ICG) technology is showing promising results in several fields of surgical oncology.
The clinical value of NIR/ICG (near infrared range/indocyanine green) technology in surgical treatment of advanced gastric cancer (AGC) is not clearly established and data regarding whether its application is associated with a change of the intraoperative surgical conduct are lacking in literature.
This is the "iGreenGO (indocyanine Green Gastric Observation) Study" protocol: an international, prospective, multicentre, study.
Study population will be a cohort of western patients who will undergo preoperative upper gastrointestinal endoscopy at the most 20 hours before surgery (intraoperative endoscopic injection before starting surgical dissection is also allowed) with submucosal peritumoral ICG injection and curative-intent gastrectomy with D2 lymphadenectomy for locally AGC.
The primary endpoint will be the incidence of "change of the surgical conduct" (CSC) at the moment of intraoperative NIR/ICG technology activation after a D2 lymphadenectomy performed "with the naked eye". Secondary endpoints will be the preoperative clinical variables potentially associated with CSC, the pattern of abdominal fluorescence distribution according to tumor and patient characteristics, the number of additional lymph nodes retrieved using NIR/ICG technology, the incidence of stage migration due to NIR/ICG application, 90-day morbidity and mortality The iGreenGO Study will be the first Western study to investigate the clinical role of NIR/ICG technology for surgical treatment of AGC in a large cohort of western patients. Results from the present study could provide novel information about which help NIR/ICG technology can supply to surgeons during lymphadenectomy for AGC and the patterns of ICG abdominal fluorescence distribution according to tumor and patient characteristics, which are unanswered questions at present time.
- Conditions
- Gastric Cancer
- Being tested
- imaging fluorescence NIR/ICG
- Keywords
- advanced, gastric cancer, indocyanine green, ICG, surgery, D2 lymphadenectomy, surgical conduct
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imaging fluorescence NIR/ICGProcedure or surgery
Also called indocyanine green
Preoperative upper GI endoscopy (UGE) UGE with submucosal injection of 2ml of ICG 0.125mg/ml solution to four peritumoral sites 15-20 hours before surgery Surgery D2 Distal gastrectomy with dissection of 1, 3, 4sb, 4sd, 5, 6, 7, 8a, 9, 11p, 12a lymph node stations (LNS) D2 Total gastrectomy with dissection of 1, 2, 3, 4sa, 4sb, 4d, 5, 6, 7, 8a, 9, 11p, 11d, 12a LNS Intraoperative NIR/ICG technology, "change of surgical conduct" (CSC) A visualization of the operative field (OF) with NIR/ICG technology is performed at the beginning of surgery and before to dissect each LNS. Subsequently, surgery is performed "with the naked eye".
At the end, a visualization of the OF is performed using NIR/ICG technology to verify whether residual lymph nodes in each D2 nodal station exist. CSC is defined as the occurring of the following situation: in case of persistence of nodal fluorescence in D2 nodal stations, the completion of the dissection of the residual nodal fluorescent structures.
| Study group | Role | What they receive |
|---|---|---|
| Gastric cancer | Male and female subjects, over 18 years of age, with histological diagnosis of locally advanced gastric carcinoma (AGC), surgically resectable, without evidence of distant metastases (cT2-T4a; N0-3; M0) for which a surgical intervention with curative purposes is indicated both as a first treatment and following preoperative neoadjuvant chemotherapy Receives: Procedure: imaging fluorescence NIR/ICG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical conduct
Incidence of "change of the surgical conduct" (CSC) at the moment of intraoperative NIR/ICG technology activation after a D2 lymphadenectomy performed "with the naked eye"
Measured: During surgical intervention (hours)
Secondary outcomes (2)
Nodal fluorescence distribution
Pattern of nodal fluorescence distribution according to tumor and patient characteristics
Measured: During surgical intervention (hours)
Clinical variables associated with change of the surgical conduct
Identification of preoperative clinical variables potentially associated with change of the surgical conduct
Measured: During surgical intervention (hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Jan 2022
- Primary completion31 Aug 2024
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pietro M Lombardi, MD, Principal investigator, Division of Minimally Invasive Surgical Oncology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943484
- Sponsor's protocol ID
- 380-09062021
- Acronym
- iGreenGO
- Status last verified
- Apr 2026
- First submitted
- 21 Jun 2021
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Monthly planned meeting among researchers
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [The iGreenGO Study]. Investigation About the Clinical Value of Indocyanine Green Imaging Fluorescence (NIR/ICG) Technology as a Modifier of Surgeon's Conduct During Curative Treatment of Advanced Gastric Cancer. Study Protocol for a Western, Observational, Prospective, Multicentric Study
- ClinicalTrials.gov ID
- NCT04943484
- Acronym / sponsor ID
- iGreenGO / 380-09062021
- Conditions
- Gastric Cancer
- Keywords
- advanced, gastric cancer, indocyanine green, ICG, surgery, D2 lymphadenectomy, surgical conduct
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Near infra-red/ indocyanine green imaging fluorescence (NIR/ICG) technology is showing promising results in several fields of surgical oncology.
The clinical value of NIR/ICG (near infrared range/indocyanine green) technology in surgical treatment of advanced gastric cancer (AGC) is not clearly established and data regarding whether its application is associated with a change of the intraoperative surgical conduct are lacking in literature.
This is the "iGreenGO (indocyanine Green Gastric Observation) Study" protocol: an international, prospective, multicentre, study.
Study population will be a cohort of western patients who will undergo preoperative upper gastrointestinal endoscopy at the most 20 hours before surgery (intraoperative endoscopic injection before starting surgical dissection is also allowed) with submucosal peritumoral ICG injection and curative-intent gastrectomy with D2 lymphadenectomy for locally AGC.
The primary endpoint will be the incidence of "change of the surgical conduct" (CSC) at the moment of intraoperative NIR/ICG technology activation after a D2 lymphadenectomy performed "with the naked eye". Secondary endpoints will be the preoperative clinical variables potentially associated with CSC, the pattern of abdominal fluorescence distribution according to tumor and patient characteristics, the number of additional lymph nodes retrieved using NIR/ICG technology, the incidence of stage migration due to NIR/ICG application, 90-day morbidity and mortality The iGreenGO Study will be the first Western study to investigate the clinical role of NIR/ICG technology for surgical treatment of AGC in a large cohort of western patients. Results from the present study could provide novel information about which help NIR/ICG technology can supply to surgeons during lymphadenectomy for AGC and the patterns of ICG abdominal fluorescence distribution according to tumor and patient characteristics, which are unanswered questions at present time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric cancer | – | Procedure: imaging fluorescence NIR/ICGMale and female subjects, over 18 years of age, with histological diagnosis of locally advanced gastric carcinoma (AGC), surgically resectable, without evidence of distant metastases (cT2-T4a; N0-3; M0) for which a surgical intervention with curative purposes is indicated both as a first treatment and following preoperative neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects, over 18 years of age, with histological diagnosis of locally advanced gastric carcinoma (AGC), surgically resectable, without evidence of distant metastases (cT2-T4a; N0-3; M0) for which a surgical intervention with curative purposes is indicated both as a first treatment and following preoperative neoadjuvant chemotherapy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imaging fluorescence NIR/ICGAlso: indocyanine greenPreoperative upper GI endoscopy (UGE) UGE with submucosal injection of 2ml of ICG 0.125mg/ml solution to four peritumoral sites 15-20 hours before surgery Surgery D2 Distal gastrectomy with dissection of 1, 3, 4sb, 4sd, 5, 6, 7, 8a, 9, 11p, 12a lymph node stations (LNS) D2 Total gastrectomy with dissection of 1, 2, 3, 4sa, 4sb, 4d, 5, 6, 7, 8a, 9, 11p, 11d, 12a LNS Intraoperative NIR/ICG technology, "change of surgical conduct" (CSC) A visualization of the operative field (OF) with NIR/ICG technology is performed at the beginning of surgery and before to dissect each LNS. Subsequently, surgery is performed "with the naked eye". At the end, a visualization of the OF is performed using NIR/ICG technology to verify whether residual lymph nodes in each D2 nodal station exist. CSC is defined as the occurring of the following situation: in case of persistence of nodal fluorescence in D2 nodal stations, the completion of the dissection of the residual nodal fluorescent structures. | Procedure or surgery | Gastric cancer |
Primary outcome
Surgical conduct
Time frame: During surgical intervention (hours)
Incidence of "change of the surgical conduct" (CSC) at the moment of intraoperative NIR/ICG technology activation after a D2 lymphadenectomy performed "with the naked eye"
2 secondary outcomes
Nodal fluorescence distribution
Time frame: During surgical intervention (hours)
Clinical variables associated with change of the surgical conduct
Time frame: During surgical intervention (hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Yes. Monthly planned meeting among researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pietro M Lombardi, MD principal investigator
Division of Minimally Invasive Surgical Oncology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Niguarda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pietro M Lombardi, MD (+39026444 ext. 4570, pietrom.lombardi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical conduct (time frame: During surgical intervention (hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.