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

NCT06840418RecruitingNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Obstetrics & Gynecology Hospital of Fudan University

Enrollment

15

Start Date

2025-01-01

Completion Date

2027-12-01

Study Type

INTERVENTIONAL

Official Title

Exploratory Study on Near-Infrared Fluorescence Imaging Technology Combined with Indocyanine Green Guided Cervical Cancer Lymph Node Metastasis

Interventions

Indocyanine green (ICG) injection for intraoperative lymph node imaging

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

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

Time frame: 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.

Locations

The Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China

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