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OncoMatch/Clinical Trials/NCT07835087

Image-Guided Platform-Assisted Sentinel Lymph Node Retrieval in Early Gastric Cancer

Official title: Image-Guided Platform-Assisted Intraoperative and Postoperative Sentinel Lymph Node Retrieval in Early Gastric Cancer: A Prospective Randomized Controlled Trial

Is NCT07835087 recruiting? Yes, currently enrolling (Oct 2026). This NA trial studies Image-Guided Retrieval Specimen Platform for early gastric cancer.

NARecruitingBeijing Friendship HospitalNCT07835087Data as of Oct 2026Location: China

Treatment: Image-Guided Retrieval Specimen Platform — This prospective, single-center, randomized controlled trial aims to evaluate the clinical effectiveness of an Image-Guided Platform assisted by a deep learning model for sentinel lymph node (SLN) retrieval in patients with early gastric cancer undergoing laparoscopic-endoscopic cooperative surgery combined with sentinel lymph node navigation surgery (LECS-SNNS). A total of 36 eligible participants will be randomly assigned in a 1:1 ratio to either the Image-Guided Platform group or the Traditional Palpation group. Both groups will undergo standardized indocyanine green fluorescence-guided sentinel lymphatic basin dissection and initial retrieval of fluorescent sentinel lymph nodes. In the experimental group, the remaining sentinel lymphatic basin (SLB) tissue will be examined using the Image-Guided Platform, which integrates radiographic and optical imaging with a deep learning model to identify and localize suspected lymph nodes. In the control group, LN retrieval will be performed using traditional visual inspection and palpation. The primary objective is to determine whether Image-Guided Platform-assisted LN retrieval increases the total number of SLNs retrieved intraoperatively compared with Traditional Palpation. Secondary objectives include assessment of LN retrieval efficiency, pathological findings, additional LN identification during permanent pathological examination, concordance between intraoperative frozen-section and permanent pathological examination, and other procedural, pathological, technical, and clinical outcomes relevant to the feasibility and performance of the Image-Guided Platform and deep learning model.

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Extracted eligibility criteria

Treatments studied

Other

Image-Guided Retrieval Specimen Platform

Cancer type

Gastric Cancer

Disease stage

Required: Stage CT1N0M0

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≤ 80

Prior therapy

Cannot have received: gastrointestinal surgery

Previous gastrointestinal surgery

Cannot have received: chemotherapy

Previous chemotherapy

Cannot have received: radiation therapy

Previous radiotherapy

Lab requirements

Blood counts

adequate bone marrow function to tolerate the planned surgical and perioperative management

Kidney function

adequate renal function to tolerate the planned surgical and perioperative management

Liver function

adequate hepatic function to tolerate the planned surgical and perioperative management

Cardiac function

adequate cardiac function to tolerate the planned surgical and perioperative management

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07835087 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior gastrointestinal surgery, chemotherapy, radiation therapy disqualifies patients from enrollment.

What disease stage is eligible?

Stage CT1N0M0 is required.

Is there an age limit?

Yes. Patients must be 80 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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