Exploring new imaging technology for cervical cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This exploratory study investigates the use of near-infrared fluorescence imaging technology combined with indocyanine green (ICG) to enhance the detection of lymph node metastasis during cervical cancer surgeries. The study aims to establish an artificial intelligence model to predict lymph node metastasis and improve surgical outcomes by refining surgical procedures. Patients undergoing radical hysterectomy and pelvic lymph node dissection will be included, and their postoperative pathology results will serve as the gold standard for evaluating the effectiveness of the imaging technique. Additionally, the quality of life of participants will be monitored post-surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Obstetrics and Gynecology Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.