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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04224467
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
Chinese Academy of Sciences
Information provided by (Responsible Party):
Chen Chunlin, Southern Medical University, China

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Chunlin Chen, MD/PhD +8613725263051 ccl1@smu.edu.cn

Locations
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China, Guangdong
Southern Medical Universtity, China Recruiting
Guangzhou, Guangdong, China, 510515
Contact: chunlin chen, MD/PhD    +8613725263051    ccl1@smu.edu.cn   
Sponsors and Collaborators
Chen Chunlin
Chinese Academy of Sciences

Publications of Results:

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Responsible Party: Chen Chunlin, Department of Obstetrics and Gynecology, Southern Medical University, China
ClinicalTrials.gov Identifier: NCT04224467    
Other Study ID Numbers: NFEC-2019-242
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Cysts
Ovarian Neoplasms
Ovarian Cysts
Endometriosis
Adenomyosis
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Pathological Conditions, Anatomical
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders