Exploring new imaging technology for cervical cancer surgery

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

This study is testing a new imaging technology to help doctors find cancer spread in lymph nodes during cervical cancer surgery to see if it can improve surgery results for patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Obstetrics & Gynecology Hospital of Fudan University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06840418 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18 to 75 with primary cervical cancer stages I to III who are undergoing radical hysterectomy and pelvic lymph node dissection.

Not a fit: Patients with a history of other malignant tumors within the last 5 years or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate surgical procedures and improved outcomes for patients with cervical cancer.

How similar studies have performed: While the use of ICG in surgical oncology has been explored, the combination with AI for predicting lymph node metastasis in cervical cancer is a novel approach.

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.

Where this trial is running

Shanghai, Shanghai Municipality

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

Conditions Uterine Cervical Neoplasms