Using Indocyanine Green to Identify Pelvic Nerves During Cervical Cancer Surgery
Single Center Clinical Study of Intravenous Indocyanine Green in Pelvic Nerve Visualization During Radical Hysterectomy for Cervical Cancer
This study is testing if a special dye can help doctors see pelvic nerves better during surgery for cervical cancer to see if it improves bladder and pelvic floor function afterward.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Fifth Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Zhuhai, Guangdong) |
| Trial ID | NCT05087264 on ClinicalTrials.gov |
What this trial studies
This clinical study involves administering indocyanine green intravenously to patients with cervical cancer prior to surgery. The aim is to visualize pelvic nerves using an infrared imaging system during radical resection of type C cervical cancer. The study is open, randomized, and prospective, with 86 patients being assigned to either the indocyanine green group or a routine surgery group to compare urinary and pelvic floor function outcomes. The research will also confirm the pathological type and clinical staging of the cancer before surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with newly diagnosed cervical squamous or adenocarcinoma suitable for radical resection.
Not a fit: Patients with unclear preoperative clinical stages or those who do not meet the surgical indications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance nerve preservation during surgery, potentially improving bladder function and quality of life for patients.
How similar studies have performed: While the use of indocyanine green in surgical settings is gaining interest, this specific application for pelvic nerve visualization in cervical cancer surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zhuhai, Guangdong
- FifthSunYetSen — Zhuhai, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: HL Nie
- Email: 95862456@qq.com
- Phone: 13539586288
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.