The Application of Real-Time Near-infrared Imaging in Gynecological Surgery
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|ClinicalTrials.gov Identifier: NCT04224467|
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : January 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Ovarian Tumor Endometrial Carcinoma Uterine Myomatosis Adenomyosis Ovarian Cyst Benign Ovarian Cyst Malignant Endometriosis Uterine Sarcoma||Other: Intravenous ICG and Real-Time Near-infrared Imaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Real-Time Identification of Lesions and Nerves by Using Indocyanine Green Fluorescent Imaging in Gynecological Surgery|
|Actual Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||November 2024|
Experimental: Indocyanine Green Fluorescent Imaging
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.
Other: Intravenous ICG and Real-Time Near-infrared Imaging
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 real-time near-infrared imaging will be conducted during surgery.
- The value and feasibility of real-time near-infrared imaging in the identification of lesions [ Time Frame: 4 years ]Evaluation of the effectiveness of real-time near-infrared imaging in detecting the margin of in situ lesions, whether there is metastasis lesions and whether the metastasis lesions has been completely removed , lymph node metastasis or not during gynecological surgery. The criteria of evaluation is postoperative pathological results and fluorescence intensity of specimen sections measured by laser scanning confocal microscope.
- The value and feasibility of real-time near-infrared imaging in the identification of nerves [ Time Frame: 4 years ]Evaluation of the effectiveness of real-time near-infrared imaging in detecting nerves associated with gynecological surgery, including the pelvic autonomic nerves composed of the abdominal aortic plexus, the superior hypogastric plexus, the hypogastric nerves, the pelvic splanchnic nerves, the inferior hypogastric plexus and its branches, obturator nerves, genitofemoral nerve, etc.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04224467
|Contact: Chunlin Chen, MD/PhDemail@example.com|
|Southern Medical Universtity, China||Recruiting|
|Guangzhou, Guangdong, China, 510515|
|Contact: chunlin chen, MD/PhD +8613725263051 firstname.lastname@example.org|