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AI platform aims to help surgeons find hidden lymph nodes in stomach cancer

NCT ID NCT07835087

Diagnosis Sponsor: Beijing Friendship 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 22, 2026 · Last updated Sep 23, 2026 · Updated 1 time

Summary

Researchers test whether an image-guided platform with a deep learning model helps surgeons retrieve more sentinel lymph nodes during surgery for early gastric cancer. The trial enrolls 36 adults with early-stage gastric adenocarcinoma who are scheduled for a specific minimally invasive surgery. Participants are randomly assigned to have lymph nodes retrieved either with the platform's imaging and AI guidance or with traditional visual inspection and palpation. The main question is whether the platform increases the total number of lymph nodes found and removed during surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an image-guided specimen retrieval platform that uses radiographic and optical imaging with a deep learning model to help surgeons locate lymph nodes
What this could lead to
If it works, this could help surgeons find more lymph nodes during surgery for early gastric cancer, which may lead to more accurate staging and better treatment decisions.
What could go wrong
This is a small, single-center trial with 36 participants, so the results may not apply to other hospitals or surgeons. The deep learning model may miss lymph nodes or flag tissue that turns out not to be a lymph node, and the technology may not improve on careful human palpation.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 36 people

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

Started

Aug 2026

Expected to finish

Aug 2027

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.

Ages

18 to 80 years

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: 1. Age between 18 and 80 years, inclusive. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and considered able to tolerate surgery and anesthesia. 3. Histologically confirmed gastric adenocarcinoma based on preoperative endoscopic biopsy. 4. Clinical stage cT1N0M0 based on multidisciplinary evaluation and appropriate preoperative examinations, including endoscopy and imaging, or patients after non-curative endoscopic submucosal dissection (ESD) who are considered appropriate candidates for further surgical treatment. 5. Adequate hepatic, renal, cardiac, pulmonary, and bone marrow function to tolerate the planned surgical and perioperative management. 6. Considered clinically suitable for laparoscopic-endoscopic cooperative surgery combined with sentinel lymph node navigation surgery (LECS-SNNS). 7. Able to understand the study procedures and provide written informed consent voluntarily. Exclusion Criteria: 1. Patients who meet the absolute indications for endoscopic submucosal dissection according to the applicable Chinese gastric cancer treatment guidelines. 2. Contraindications to the use of the lymphatic tracer or to endoscopic examination. 3. Unable to undergo ESD or failure of ESD treatment. 4. Inability to determine the extent of tracer staining or fluorescence mapping. 5. Contraindications to surgery, including clinically significant coagulation disorders or severe cardiopulmonary dysfunction. 6. Previous gastrointestinal surgery, chemotherapy, or radiotherapy. 7. Preoperative imaging indicating bulky, conglomerated, or markedly enlarged metastatic lymph nodes. 8. Concurrent malignancy involving another organ system, or intraoperative confirmation of metastatic gastric cancer or a non-gastric primary malignancy. 9. Pregnancy or breastfeeding. 10. Psychiatric disorders, cognitive impairment, or other conditions that impair the ability to provide informed consent or comply with study procedures. 11. Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastric neoplasm microinvasive gastric cancer

As listed by the trial registrant

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

Early gastric cancer Gastric adenocarcinoma

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

  • Beijing Friendship Hospital, Capital Medical University

    RECRUITING

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.