Clinical Study of Indocyanine Green Displaying Pelvic Nerve in Radical Operation of Cervical Cancer

• Status: Not yet recruiting
• Trial end date: 2025-10-16
• Target enrollment: 0
• Participant gender: Female

Summary

Indocyanine green was injected intravenously into patients with cervical cancer before operation. The nerve development was observed by infrared imaging system during operation, which was used as the basis for nerve preserving operation of type C cervical cancer. The recovery of bladder function was observed.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University

Criteria

Inclusion Criteria:

1. The subjects have certain reading ability, can communicate effectively with the researchers, and voluntarily sign the informed consent form

2. they are 18-75 years old (including the boundary value) and the ECoG score is 0-1

3. Patients with newly diagnosed cervical squamous epithelial carcinoma and cervical adenocarcinoma confirmed by histology

4. according to NCCN guidelines, they are suitable for patients undergoing radical resection of q-m C1 cervical cancer, i.e. IB1 stage deep interstitial infiltrators / ib2-iia2 stage and early IIB stage

5. normal range of liver and kidney function: bilirubin ≤ 1.5 times ULN, ALT and AST ≤ 2.5 times ULN, creatinine ≤ 1.5 times ULN, Or creatinine clearance rate ≥ 50ml / min (using standard Cockroft Gault formula)

6. have good review and follow-up conditions, and be followed up for at least 1 year

Exclusion Criteria:

1. The preoperative clinical stage was unclear and the surgical indications were controversial

2. Previous history of malignant tumor or radiotherapy or chemotherapy or antiangiogenic therapy

3. pathological types are neuroendocrine carcinoma, small cell tumor, clear cell carcinoma, sarcoma and other histological types

4. urinary disease obstruction and hydronephrosis

5. severe congestive heart failure of grade II or above of New York Heart Association, History of myocardial infarction or unstable angina pectoris within 6 months before operation; Stroke or transient ischemic attack within 6 months before operation

6. pregnancy or lactation

7. according to the judgment of the investigator, it may increase the risk related to the study, may interfere with the interpretation of the study results, or the investigator believes that the patients are not suitable for inclusion