Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
FEMALE
NCT06840418

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

Led by Obstetrics & Gynecology Hospital of Fudan University · Updated on 2025-02-21

15

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with primary cervical cancer stages I to III, no restrictions on pathological type
  • Age 18 to 75 years
  • Patients who have undergone radical or modified radical hysterectomy (Q-M surgery type B or C) plus pelvic lymph node dissection
  • Complete preoperative clinical and postoperative pathological data available
  • Normal liver and kidney function and blood test results within specified ranges: Hemoglobin >60 g/L; Platelets >70 x 10^9/L; White blood cells >3 x 10^9/L; Creatinine <50 mg/dL; liver enzyme abnormalities ≤3 items; highest liver enzyme value ≤3 times normal
  • No history of other malignant tumors within 5 years
  • Not pregnant
  • Karnofsky performance status ≥60 or ECOG score 0 to 1
  • Volunteers willing to sign informed consent, with good compliance and follow-up cooperation
  • No mental illness, serious infectious diseases, or immune system diseases such as lupus erythematosus, myasthenia gravis, or HIV infection
Not Eligible

You will not qualify if you...

  • Allergy to indocyanine green or iodine
  • Contraindications to surgery preventing surgical treatment
  • Recurrent cervical cancer
  • Participation in other clinical trials within the past 3 months
  • Other conditions deemed unsuitable by the investigator or diseases that could affect study results
  • Preoperative assessment indicating inability to tolerate surgery due to systemic or organ conditions
  • Unwilling or unable to provide written informed consent or comply with follow-up requirements

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 200090

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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