Cervical CancerNCT04224467
The Application of Real-Time Near-infrared Imaging in Gynecological Surgery
A study testing Intravenous ICG and Real-Time Near-infrared Imaging in people with Cervical Cancer and Ovarian Tumor, run by Chen Chunlin at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cervical Cancer, Ovarian Tumor, Endometrial Carcinoma
- What is being tested?
- Intravenous ICG and Real-Time Near-infrared Imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Less than 6 months expectancy life;
- Patients with iodine allergy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southern Medical Universtity, China
Guangzhou, Guangdong, 510515
chunlin chen, MD/PhD, +8613725263051, ccl1@smu.edu.cn
About this study
Official title: Real-Time Identification of Lesions and Nerves by Using Indocyanine Green Fluorescent Imaging in Gynecological Surgery
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
- Being tested
- Intravenous ICG and Real-Time Near-infrared Imaging
- Medical subject headings
- Uterine Cervical Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Adenomyosis, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ICG and Real-Time Near-infrared ImagingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Indocyanine Green Fluorescent Imaging | Experimental | 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. Receives: Other: Intravenous ICG and Real-Time Near-infrared Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Jan 2020
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Chunlin
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Responsible party
- Sponsor-investigator, Chen Chunlin, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224467
- Sponsor's protocol ID
- NFEC-2019-242
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29935649Gossedge 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.
PubMed 26394736Cosentino 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.
PubMed 29551477Malzoni 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.
PubMed 31325591He 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.
PubMed 29290809Chen 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.
PubMed 25199746Mao 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.
PubMed 28950327Li 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.
PubMed 36450938He 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.
PubMed 35230489
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Identification of Lesions and Nerves by Using Indocyanine Green Fluorescent Imaging in Gynecological Surgery
- ClinicalTrials.gov ID
- NCT04224467
- Acronym / sponsor ID
- NFEC-2019-242
- Conditions
- Cervical Cancer, Ovarian Tumor, Endometrial Carcinoma, Uterine Myomatosis, Adenomyosis, Ovarian Cyst Benign
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chen ChunlinUniversity, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indocyanine Green Fluorescent Imaging | Experimental | Other: Intravenous ICG and Real-Time Near-infrared ImagingPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Less than 6 months expectancy life;
- Patients with iodine allergy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous ICG and Real-Time Near-infrared ImagingPatients 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. | Other | Indocyanine Green Fluorescent Imaging |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Results publication: PubMed 29935649Seracchioli 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.
- Results publication: PubMed 26394736Gossedge 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.
- Results publication: PubMed 29551477Cosentino 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.
- Results publication: PubMed 31325591Malzoni 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.
- Results publication: PubMed 29290809He 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.
- Results publication: PubMed 25199746Chen 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.
- Results publication: PubMed 28950327Mao 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.
- Derived from this study: PubMed 36450938Li 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.
- Derived from this study: PubMed 35230489He 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous ICG and Real-Time Near-infrared Imaging in people with Cervical Cancer and Ovarian Tumor, run by Chen Chunlin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunlin Chen, MD/PhD (+8613725263051, ccl1@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The value and feasibility of real-time near-infrared imaging in the identification of lesions (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04224467, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.