Cervical CarcinomaEarly Phase 1NCT05087264
Clinical Study of Indocyanine Green Displaying Pelvic Nerve in Radical Operation of Cervical Cancer
A Early Phase 1 study testing Indocyanine green in people with Cervical Carcinoma, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Indocyanine green was injected intravenously into patients with cervical cancer before operation. The nerve development was observed by infrared imaging system during operation, which was used as the basis for nerve preserving operation of type C cervical cancer. The recovery of bladder function was observed. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Carcinoma
- What is being tested?
- Indocyanine green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2022to 16 Oct 2025
- Phase
- Early Phase 1
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects have certain reading ability, can communicate effectively with the researchers, and voluntarily sign the informed consent form
- they are 18-75 years old (including the boundary value) and the ECoG score is 0-1
- Patients with newly diagnosed cervical squamous epithelial carcinoma and cervical adenocarcinoma confirmed by histology
- according to NCCN guidelines, they are suitable for patients undergoing radical resection of q-m C1 cervical cancer, i.e. IB1 stage deep interstitial infiltrators / ib2-iia2 stage and early IIB stage
- normal range of liver and kidney function: bilirubin ≤ 1.5 times ULN, ALT and AST ≤ 2.5 times ULN, creatinine ≤ 1.5 times ULN, Or creatinine clearance rate ≥ 50ml / min (using standard Cockroft Gault formula)
- have good review and follow-up conditions, and be followed up for at least 1 year
Who cannot join
- The preoperative clinical stage was unclear and the surgical indications were controversial
- Previous history of malignant tumor or radiotherapy or chemotherapy or antiangiogenic therapy
- pathological types are neuroendocrine carcinoma, small cell tumor, clear cell carcinoma, sarcoma and other histological types
- urinary disease obstruction and hydronephrosis
- severe congestive heart failure of grade II or above of New York Heart Association, History of myocardial infarction or unstable angina pectoris within 6 months before operation; Stroke or transient ischemic attack within 6 months before operation
- pregnancy or lactation
- according to the judgment of the investigator, it may increase the risk related to the study, may interfere with the interpretation of the study results, or the investigator believes that the patients are not suitable for inclusion
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
FifthSunYetSen
Zhuhai, Guangdong, 519000
Huilong Nie, Doc., 13727081129, 95862456@qq.com
About this study
Official title: Single Center Clinical Study of Intravenous Indocyanine Green in Pelvic Nerve Visualization During Radical Hysterectomy for Cervical Cancer
Indocyanine green was injected intravenously into patients with cervical cancer before operation. The nerve development was observed by infrared imaging system during operation, which was used as the basis for nerve preserving operation of type C cervical cancer. The recovery of bladder function was observed.
Read the detailed description
This study is an open, randomized and prospective clinical study. 86 patients are planned to be randomly assigned according to 1:1. 43 patients underwent preoperative intravenous injection of indocyanine green, radical resection of q-mc1 cervical cancer under pelvic autonomic nerve fluorescence, and 43 patients underwent routine surgery to observe the medium and long-term urinary system function and pelvic floor function of the subjects.
Before operation, confirm the pathological type, pelvic and abdominal enhancement CT or MRI examination, urography (if necessary), two researchers with senior professional title of gynecology respectively carry out gynecological double diagnosis and triple diagnosis examination, and carry out clinical staging according to figo2018 staging standard; According to NCCN guidelines, subjects who are suitable for radical resection of q-m type C1 cervical cancer (IB1 stage deep interstitial Infiltrator / ib2-iia2 stage) are enrolled for routine preoperative examination, and surgical contraindications are excluded. The operation method is open radical resection of q-m C1 cervical cancer. The same group of researchers with rich experience in gynecological tumor operation act as the chief surgeon. Gradually open the retroperitoneum, walk along the ureter to complete anatomical exposure, observe and record the fluorescence staining degree of pelvic autonomic nerve at different time nodes, and compare with the surrounding blood vessels / lymphatic vessels / adipose tissue, Observe the bladder branch of pelvic visceral nerve, dissociate the pelvic visceral nerve plexus from the rectum uterus / rectocervical ligament, preserve the nerve tissue behind the ureter and bladder, and perform extensive resection.
The shape map of pelvic autonomic nerve (including near-infrared region I and region II) was developed. The researchers recorded the identification of nerve after operation and recorded the best observation time point.
The researchers recorded the operation time, the amount of bleeding, the length of the resected uterosacral ligament, main ligament and bladder cervical ligament, and the distal margin was reserved for nerve staining and quantitative analysis.
Safety observation: allergic reaction, influence on liver and kidney function, influence on hemagglutination state.
Observation of recent indicators of bladder dysfunction after operation: the catheter was removed 1 week after operation, and the residual urine volume was measured by ultrasonography. The catheter was placed again if it was > 100ml, and then rechecked once a week until the residual urine volume was less than 30ml.
- Conditions
- Cervical Carcinoma
- Being tested
- Indocyanine green
- Keywords
- Cervical Carcinoma, Indocyanine green, Neural phenomenon, Infrared imaging
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine greenDrug
ICG retention test and clearance test: intravenous injection, 0.5mg/l. Liver blood flow measurement: intravenous drip, dissolve 25mg ICG in 100ml injection water, and drip at a constant speed for about 50min to make the ICG concentration reach equilibrium.
| Study group | Role | What they receive |
|---|---|---|
| Indocyanine green injection | Experimental | 43 cases received preoperative intravenous injection of indocyanine green and radical resection of q-mc1 cervical cancer under pelvic autonomic nerve fluorescence development Receives: Drug: Indocyanine green |
| Not Indocyanine green injection | No intervention | 43 cases underwent routine surgery，not indocyanine green injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main indicators of bladder function recovery
Residual urine volume of bladder 7 days after operation
Measured: 7 days after operation
Secondary outcomes (1)
Other indicators of bladder function recovery
① Micturition time, micturition times, tension urinary incontinence, prolonged micturition time, abdominal pressure micturition, incomplete micturition and dysuria; ② Urodynamic examination, monitoring the maximum urinary flow rate (MFR), average urinary flow rate (AFR), residual urine volume (RU), initial urinary bladder volume (FVS), maximum urinary bladder volume (MVS), detrusor contraction and maximum detrusor contraction force (MDP); ③ Pelvic floor function evaluation: pelvic floor function examination was performed 24 weeks after operation.
Measured: 12, 24 and 48 weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start10 Mar 2022 (estimated)
- Primary completion16 Oct 2025 (estimated)
- Study completion16 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CarcinomaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group, control group
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087264
- Sponsor's protocol ID
- ZDWY.FK.001
- Status last verified
- Sep 2021
- First submitted
- 25 Sep 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Clinical Study of Intravenous Indocyanine Green in Pelvic Nerve Visualization During Radical Hysterectomy for Cervical Cancer
- ClinicalTrials.gov ID
- NCT05087264
- Acronym / sponsor ID
- ZDWY.FK.001
- Conditions
- Cervical Carcinoma
- Keywords
- Cervical Carcinoma, Indocyanine green, Neural phenomenon, Infrared imaging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 10 Mar 2022 (estimated)
- Primary completion
- 16 Oct 2025 (estimated)
- Study completion
- 16 Oct 2025 (estimated)
- First posted
- 21 Oct 2021 (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.
Indocyanine green was injected intravenously into patients with cervical cancer before operation. The nerve development was observed by infrared imaging system during operation, which was used as the basis for nerve preserving operation of type C cervical cancer. The recovery of bladder function was observed.
Detailed description
This study is an open, randomized and prospective clinical study. 86 patients are planned to be randomly assigned according to 1:1. 43 patients underwent preoperative intravenous injection of indocyanine green, radical resection of q-mc1 cervical cancer under pelvic autonomic nerve fluorescence, and 43 patients underwent routine surgery to observe the medium and long-term urinary system function and pelvic floor function of the subjects.
Before operation, confirm the pathological type, pelvic and abdominal enhancement CT or MRI examination, urography (if necessary), two researchers with senior professional title of gynecology respectively carry out gynecological double diagnosis and triple diagnosis examination, and carry out clinical staging according to figo2018 staging standard; According to NCCN guidelines, subjects who are suitable for radical resection of q-m type C1 cervical cancer (IB1 stage deep interstitial Infiltrator / ib2-iia2 stage) are enrolled for routine preoperative examination, and surgical contraindications are excluded. The operation method is open radical resection of q-m C1 cervical cancer. The same group of researchers with rich experience in gynecological tumor operation act as the chief surgeon. Gradually open the retroperitoneum, walk along the ureter to complete anatomical exposure, observe and record the fluorescence staining degree of pelvic autonomic nerve at different time nodes, and compare with the surrounding blood vessels / lymphatic vessels / adipose tissue, Observe the bladder branch of pelvic visceral nerve, dissociate the pelvic visceral nerve plexus from the rectum uterus / rectocervical ligament, preserve the nerve tissue behind the ureter and bladder, and perform extensive resection.
The shape map of pelvic autonomic nerve (including near-infrared region I and region II) was developed. The researchers recorded the identification of nerve after operation and recorded the best observation time point.
The researchers recorded the operation time, the amount of bleeding, the length of the resected uterosacral ligament, main ligament and bladder cervical ligament, and the distal margin was reserved for nerve staining and quantitative analysis.
Safety observation: allergic reaction, influence on liver and kidney function, influence on hemagglutination state.
Observation of recent indicators of bladder dysfunction after operation: the catheter was removed 1 week after operation, and the residual urine volume was measured by ultrasonography. The catheter was placed again if it was > 100ml, and then rechecked once a week until the residual urine volume was less than 30ml.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental group, control group
| Arm | Type | Receives |
|---|---|---|
| Indocyanine green injection | Experimental | Drug: Indocyanine green43 cases received preoperative intravenous injection of indocyanine green and radical resection of q-mc1 cervical cancer under pelvic autonomic nerve fluorescence development |
| Not Indocyanine green injection | No intervention | –43 cases underwent routine surgery，not indocyanine green injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subjects have certain reading ability, can communicate effectively with the researchers, and voluntarily sign the informed consent form
- they are 18-75 years old (including the boundary value) and the ECoG score is 0-1
- Patients with newly diagnosed cervical squamous epithelial carcinoma and cervical adenocarcinoma confirmed by histology
- according to NCCN guidelines, they are suitable for patients undergoing radical resection of q-m C1 cervical cancer, i.e. IB1 stage deep interstitial infiltrators / ib2-iia2 stage and early IIB stage
- normal range of liver and kidney function: bilirubin ≤ 1.5 times ULN, ALT and AST ≤ 2.5 times ULN, creatinine ≤ 1.5 times ULN, Or creatinine clearance rate ≥ 50ml / min (using standard Cockroft Gault formula)
Key exclusion criteria (7 listed)
- The preoperative clinical stage was unclear and the surgical indications were controversial
- Previous history of malignant tumor or radiotherapy or chemotherapy or antiangiogenic therapy
- pathological types are neuroendocrine carcinoma, small cell tumor, clear cell carcinoma, sarcoma and other histological types
- urinary disease obstruction and hydronephrosis
- severe congestive heart failure of grade II or above of New York Heart Association, History of myocardial infarction or unstable angina pectoris within 6 months before operation; Stroke or transient ischemic attack within 6 months before operation
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 |
|---|---|---|
| Indocyanine greenICG retention test and clearance test: intravenous injection, 0.5mg/l. Liver blood flow measurement: intravenous drip, dissolve 25mg ICG in 100ml injection water, and drip at a constant speed for about 50min to make the ICG concentration reach equilibrium. | Drug | Indocyanine green injection |
Primary outcome
Main indicators of bladder function recovery
Time frame: 7 days after operation
Residual urine volume of bladder 7 days after operation
1 secondary outcome
Other indicators of bladder function recovery
Time frame: 12, 24 and 48 weeks after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: No
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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 Early Phase 1 study testing Indocyanine green in people with Cervical Carcinoma, run by Fifth Affiliated Hospital, Sun Yat-Sen University 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 6 inclusion and 7 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 18 Mar 2022. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 HL Nie (13539586288, 95862456@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main indicators of bladder function recovery (time frame: 7 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2022.