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

NCT ID: NCT04224467

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2024-11-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intravenous ICG and Real-Time Near-infrared Imaging

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role: collaborator

Chen Chunlin

OTHER

Sponsor Role: lead

Responsible Party

Chen Chunlin

Department of Obstetrics and Gynecology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Southern Medical Universtity, China

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chunlin Chen, MD/PhD

Role: CONTACT

ccl1@smu.edu.cn

+8613725263051

Facility Contacts

chunlin chen, MD/PhD

Role: primary

ccl1@smu.edu.cn

+8613725263051

References

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.

Reference Type: RESULT

PMID: 29935649 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26394736 (View on PubMed)

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-Dec;25(7):1249-1254. doi: 10.1016/j.jmig.2018.02.023. Epub 2018 Mar 15.

Reference Type: RESULT

PMID: 29551477 (View on PubMed)

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. 2020 Feb;27(2):258. doi: 10.1016/j.jmig.2019.06.018. Epub 2019 Jul 17.

Reference Type: RESULT

PMID: 31325591 (View on PubMed)

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. eCollection 2018.

Reference Type: RESULT

PMID: 29290809 (View on PubMed)

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 Larynx. 2015 Apr;42(2):113-8. doi: 10.1016/j.anl.2014.08.008. Epub 2014 Sep 6.

Reference Type: RESULT

PMID: 25199746 (View on PubMed)

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. doi: 10.1093/ejcts/ezx207.

Reference Type: RESULT

PMID: 28950327 (View on PubMed)

Li P, Liu J, He K, Gong S, Chi C, Liu P, Su G, Li W, Duan H, Liu P, Tian J, Chen C. Tumor lesion detection in patients with cervical cancer by indocyanine green near-infrared imaging. Eur J Nucl Med Mol Imaging. 2023 Mar;50(4):1252-1261. doi: 10.1007/s00259-022-06030-1. Epub 2022 Dec 1.

Reference Type: DERIVED

PMID: 36450938 (View on PubMed)

He K, Li P, Zhang Z, Liu J, Liu P, Gong S, Chi C, Liu P, Chen C, Tian J. Intraoperative near-infrared fluorescence imaging can identify pelvic nerves in patients with cervical cancer in real time during radical hysterectomy. Eur J Nucl Med Mol Imaging. 2022 Jul;49(8):2929-2937. doi: 10.1007/s00259-022-05686-z. Epub 2022 Mar 1.

Reference Type: DERIVED

PMID: 35230489 (View on PubMed)

Other Identifiers

NFEC-2019-242

Identifier Type: -

Identifier Source: org_study_id