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

NCT ID: NCT06840418

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lymph node metastasis fluorescence imaging group

Group Type: EXPERIMENTAL

Indocyanine green (ICG) injection for intraoperative lymph node imaging

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with primary cervical cancer stages I to III, with no restrictions on pathological type.

2. Age ≥18 years old and ≤75 years old.

3. Patients who have undergone radical hysterectomy/modified radical hysterectomy (referring to the Q-M surgery classification, with surgical methods of type B and type C) + pelvic lymph node dissection.

4. Patients with complete preoperative clinical and postoperative pathological data.

5. Normal liver and kidney function and within the normal range of blood routine tests (specific details are as follows): Hemoglobin >60 g/L; Platelets >70 * 10^9/L; White blood cells >3 * 10^9/L; Creatinine <50 mg/dL; Abnormal liver enzyme indicators ≤3 items; The highest value of liver enzymes does not exceed three times the corresponding normal value.

6. No history of other malignant tumors within 5 years.

7. Not pregnant.

8. Performance status: Karnofsky score ≥60 points or ECOG score 0 to 1 points.

9. Volunteers who willingly join this study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.

10. No mental illness or other serious infectious diseases or immune system diseases (such as lupus erythematosus, myasthenia gravis, HIV infection, etc.)

Exclusion Criteria

1. Patients with allergies to ICG or iodine. Individuals with contraindications to various surgeries who cannot undergo surgery.

2. Patients with recurrent cervical cancer.

3. Patients who have participated in other clinical trials within the past 3 months.

4. Other conditions deemed unsuitable for inclusion in this study by the 5.investigator, or patients with other underlying diseases that may confound the study results.

6.Patients who are assessed preoperatively as having systemic and organ conditions that are unlikely to tolerate surgery.

7.Patients or guardians who are unwilling or unable to provide written informed consent or comply with subsequent follow-up requirements.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Obstetrics & Gynecology Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Wu Xin

Role: primary

wuxin_fc@fudan.edu.cn

86-02133189900 ext. 8613764046908

Other Identifiers

FUOBGY-2024-224

Identifier Type: -

Identifier Source: org_study_id