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Glowing dye may guide surgeons during stomach cancer operations

NCT ID NCT04943484

Knowledge-focused Sponsor: Niguarda Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether using a dye called indocyanine green (ICG) during surgery for advanced stomach cancer helps surgeons see cancer more clearly and change their approach. About 360 adults with stomach cancer will take part. The goal is to see if the dye improves how surgery is done, not to test a new cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastric cancer gastric neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASST GOM Niguarda

    RECRUITING

    Milan, Italia, 20162, Italy

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