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

NCT06840418 | Recruiting

• 1 other identifier: FUOBGY-2024-224
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The sensitivity of lymph node metastasis fluorescence imaging（Signal-to-Background Ratio）.

  The time frame was from subject enrollment until surgical pathology results were obtained. The time between subject enrollment and the availability of surgical pathology results was approximately 1 to 1.5 months.

Study Arms (1)

Lymph node metastasis fluorescence imaging group

EXPERIMENTAL

Drug: Indocyanine green (ICG) injection for intraoperative lymph node imaging

Interventions

Indocyanine green (ICG) injection for intraoperative lymph node imaging 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.

Lymph node metastasis fluorescence imaging group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with primary cervical cancer stages I to III, with no restrictions on pathological type.
• Age ≥18 years old and ≤75 years old.
• 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.
• Patients with complete preoperative clinical and postoperative pathological data.
• 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.
• No history of other malignant tumors within 5 years.
• Not pregnant.
• Performance status: Karnofsky score ≥60 points or ECOG score 0 to 1 points.
• Volunteers who willingly join this study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.
• No mental illness or other serious infectious diseases or immune system diseases (such as lupus erythematosus, myasthenia gravis, HIV infection, etc.)

You may not qualify if:

• Patients with allergies to ICG or iodine. Individuals with contraindications to various surgeries who cannot undergo surgery.
• Patients with recurrent cervical cancer.
• Patients who have participated in other clinical trials within the past 3 months.
• Patients who are assessed preoperatively as having systemic and organ conditions that are unlikely to tolerate surgery.
• Patients or guardians who are unwilling or unable to provide written informed consent or comply with subsequent follow-up requirements.

Sponsors & Collaborators

• Obstetrics & Gynecology Hospital of Fudan University: lead

Study Sites (1)

The Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200090, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Indocyanine Green; Injections

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)