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Exploratory Study on NIRFI Technology Combined with ICG Guided Cervical Cancer Lymph Node Metastasis

NCT06840418 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-02-21

No results posted yet for this study

Summary

The goal of this exploratory study is to exploring the lymph node metastasis, tumor margin, blood vessels, ureters, and nerve imaging in cervical cancer surgery using near-infrared fluorescence imaging technology combined with indocyanine green, and establishing an artificial intelligence model for predicting lymph node metastasis of cervical cancer to guide the advancement of refined surgical procedures.And the focus of this study is to investigate the situation of pelvic lymph node metastasis.The sole medication used in this experiment is the fluorescent contrast agent that has been clinically used for over 40 years - Indocyanine Green (ICG).Subsequent pathology results after the surgery will be used as the gold standard to determine the detection rate of lymph node metastasis and the accuracy of the complete resection rate of the surgical margin in cervical cancer.The researchers will also follow up on the quality of life of patients after the surgery.

The main question it aims to answer is:

can artificial intelligence multimodal fusion prediction models improve the accuracy of preoperative diagnosis of pelvic lymph node metastasis in cervical cancer? The researchers compared the AI multimodal fusion prediction model with traditional imaging physician assessments to see if the prediction model could yield more accurate lymph node metastasis determinations. Participants will undergo pelvic MRI after pathologically confirming a diagnosis of cervical cancer, and the results will be used to determine pelvic lymph node metastasis status by the predictive model and the imaging physician, respectively. Subsequent pathology results after surgical lymph node clearance will be used as the gold standard to determine the accuracy of the two preoperative lymph node diagnostic modalities.

Conditions

  • Uterine Cervical Neoplasms

Interventions

DRUG

Indocyanine green (ICG) injection for intraoperative lymph node imaging

Injection is performed at the 3 o'clock and 9 o'clock positions of the cervix, with 1 ml on each side, for a total dose of 2 ml. Injection depth: The tracer is injected into the superficial (2 mm) and deep (1 cm) layers, with the superficial injection performed first, followed by the deep injection.

Sponsors & Collaborators

  • Obstetrics & Gynecology Hospital of Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06840418 on ClinicalTrials.gov