The Application of Real-Time Near-infrared Imaging in Gynecological Surgery

Chen Chunlin

Status: Enrolling

Conditions: Uterine Myomatosis; Endometrial Carcinoma; Ovarian Cyst Benign; Ovarian Cyst Malignant; Ovarian Tumor; Uterine Sarcoma; Endometriosis; Adenomyosis; Cervical Cancer

Treatments: Other: Intravenous ICG and Real-Time Near-infrared Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT04224467

NFEC-2019-242

Details and patient eligibility

About

Removing in situ and metastasis lesions completely during gynecological surgery is central to reduce the recurrence and death, and the identification of lesions in traditional gynecological surgery often depends on the experience of surgeons. The identification of nerves is often needed in gynecological surgery, such as the obturator nerves in pelvic lymphadenectomy, and the pelvic autonomic nerves in nerve-sparing radical hysterectomy for cervical cancer. Nerve identification also relies heavily on the experience of surgeons. This project aims to realize the identification of lesions and nerves under the navigation of indocyanine green fluorescent imaging, and evaluate the accuracy of fluorescent imaging of lesions and the effectiveness of nerves identification by near-infrared imaging. This project may reduce the recurrence or death caused by residual lesions and postoperative dysfunction caused by nerves injury, thus, improve the survival rate and quality of life for patients with gynecological diseases.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with FIGO (2018) stage IA1(LVSI)-IIA2 cervical cancer，endometrial cancer，ovarian tumor, endometriosis, adenomyosis, uterine myomatosis, ovarian cyst ,or uterine sarcoma
• Patients who consent to receive indocyanine green near-infrared fluorescence-guided gynecological surgery

Exclusion criteria

• Less than 6 months expectancy life;
• Patients with iodine allergy.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Indocyanine Green Fluorescent Imaging

Experimental group

Description:

Patients will be intravenously injected ICG (Yichuang Pharmaceutical Limited Liability Company, Dandong, China) at a dose of 2-5 mg per kg of body weight before surgery or 0.25-0.5 mg per kg of body weight during surgery. Then, a NIR imaging systems included the NIR (800-900 nm) and white-light (400-650nm) dual-channel will be used to detect In situ lesions, metastatic lesions, lymph nodes, obturator nerve, pelvic autonomic nerve, etc during surgery according to disease and clinical needs.

Treatment:

Other: Intravenous ICG and Real-Time Near-infrared Imaging