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

Cervical Cancer Clinical Trial

Official title:

Real-Time Identification of Lesions and Nerves by Using Indocyanine Green Fluorescent Imaging in Gynecological Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04224467
• Other study ID #: NFEC-2019-242
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: November 2024

Study information

• Verified date: January 2020
• Source: Southern Medical University, China
• Contact: Chunlin Chen, MD/PhD
• Phone: +8613725263051
• Email: ccl1[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenomyosis
• Cervical Cancer
• Cysts
• Endometrial Carcinoma
• Endometrial Neoplasms
• Endometriosis
• Ovarian Cyst Benign
• Ovarian Cyst Malignant
• Ovarian Cysts
• Ovarian Neoplasms
• Ovarian Tumor
• Uterine Myomatosis
• Uterine Sarcoma

Intervention

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.

Locations

Country	Name	City	State
China	Southern Medical Universtity, China	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Chen Chunlin	Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

References & Publications (7)

Chen SC, Wang MC, Wang WH, Lee CC, Yang TF, Lin CF, Wang JT, Liao CH, Chang CC, Chen MH, Shih YH, Hsu SP. Fluorescence-assisted visualization of facial nerve during mastoidectomy: A novel technique for preventing iatrogenic facial paralysis. Auris Nasus L — View Citation

Cosentino F, Vizzielli G, Turco LC, Fagotti A, Cianci S, Vargiu V, Zannoni GF, Ferrandina G, Scambia G. Near-Infrared Imaging with Indocyanine Green for Detection of Endometriosis Lesions (Gre-Endo Trial): A Pilot Study. J Minim Invasive Gynecol. 2018 Nov — View Citation

Gossedge G, Vallance A, Jayne D. Diverse applications for near infra-red intraoperative imaging. Colorectal Dis. 2015 Oct;17 Suppl 3:7-11. doi: 10.1111/codi.13023. Review. — View Citation

He K, Zhou J, Yang F, Chi C, Li H, Mao Y, Hui B, Wang K, Tian J, Wang J. Near-infrared Intraoperative Imaging of Thoracic Sympathetic Nerves: From Preclinical Study to Clinical Trial. Theranostics. 2018 Jan 1;8(2):304-313. doi: 10.7150/thno.22369. eCollec — View Citation

Malzoni M, Iuzzolino D, Rasile M, Coppola M, Casarella L, Di Giovanni A, Falcone F. Surgical Principles of Segmental Rectosigmoid Resection and Reanastomosis for Deep Infiltrating Endometriosis. J Minim Invasive Gynecol. 2019 Jul 17. pii: S1553-4650(19)30 — View Citation

Mao Y, Chi C, Yang F, Zhou J, He K, Li H, Chen X, Ye J, Wang J, Tian J. The identification of sub-centimetre nodules by near-infrared fluorescence thoracoscopic systems in pulmonary resection surgeries. Eur J Cardiothorac Surg. 2017 Dec 1;52(6):1190-1196. — View Citation

Seracchioli R, Raimondo D, Arena A, Zanello M, Mabrouk M. Clinical use of endovenous indocyanine green during rectosigmoid segmental resection for endometriosis. Fertil Steril. 2018 Jun;109(6):1135. doi: 10.1016/j.fertnstert.2018.02.122. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The value and feasibility of real-time near-infrared imaging in the identification of lesions	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.	4 years
Primary	The value and feasibility of real-time near-infrared imaging in the identification of nerves	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.	4 years