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

Launched by OBSTETRICS & GYNECOLOGY HOSPITAL OF FUDAN UNIVERSITY · Feb 17, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring new ways to improve surgery for women with cervical cancer by using a special imaging technology called near-infrared fluorescence imaging (NIRFI) combined with a dye called indocyanine green (ICG). The goal is to better identify cancerous lymph nodes and ensure surgeons can remove all cancerous tissue during surgery. Researchers are also testing a new artificial intelligence model to see if it can help predict which patients have cancer spread to their lymph nodes more accurately than traditional imaging methods.

To participate, women aged 18 to 75 with early to advanced cervical cancer stages I to III may be eligible, provided they meet specific health criteria and have not had other cancers in the past five years. Participants will undergo imaging tests before their surgery, and their health and quality of life will be monitored afterward. This study is an important step in improving surgical techniques and outcomes for women facing cervical cancer.

Gender

FEMALE

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.