Uterine Cervical NeoplasmsNCT06840418
Exploratory Study on NIRFI Technology Combined with ICG Guided Cervical Cancer Lymph Node Metastasis
A study testing Indocyanine green (ICG) injection for intraoperative lymph node imaging in people with Uterine Cervical Neoplasms, run by Obstetrics & Gynecology Hospital of Fudan University at 1 site in China.
Trial summary
The goal of this exploratory study is to exploring the lymph node metastasis, tumor margin, blood vessels, ureters, and nerve imaging in cervical cancer surgery using near-infrared fluorescence imaging technology combined with indocyanine green, and establishing an artificial intelligence model for predicting lymph… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- Indocyanine green (ICG) injection for intraoperative lymph node imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with primary cervical cancer stages I to III, with no restrictions on pathological type.
- Age ≥18 years old and ≤75 years old.
- Patients who have undergone radical hysterectomy/modified radical hysterectomy (referring to the Q-M surgery classification, with surgical methods of type B and type C) + pelvic lymph node dissection.
- Patients with complete preoperative clinical and postoperative pathological data.
- Normal liver and kidney function and within the normal range of blood routine tests (specific details are as follows): Hemoglobin >60 g/L; Platelets >70 * 10^9/L; White blood cells >3 * 10^9/L; Creatinine <50 mg/dL; Abnormal liver enzyme indicators ≤3 items; The highest value of liver enzymes does not exceed three times the corresponding normal value.
- No history of other malignant tumors within 5 years.
Show all 10Show fewer
- Not pregnant.
- Performance status: Karnofsky score ≥60 points or ECOG score 0 to 1 points.
- Volunteers who willingly join this study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.
- No mental illness or other serious infectious diseases or immune system diseases (such as lupus erythematosus, myasthenia gravis, HIV infection, etc.)
Who cannot join
- Patients with allergies to ICG or iodine. Individuals with contraindications to various surgeries who cannot undergo surgery.
- Patients with recurrent cervical cancer.
- Patients who have participated in other clinical trials within the past 3 months.
- Other conditions deemed unsuitable for inclusion in this study by the 5.investigator, or patients with other underlying diseases that may confound the study results.
- 6.Patients who are assessed preoperatively as having systemic and organ conditions that are unlikely to tolerate surgery.
- 7.Patients or guardians who are unwilling or unable to provide written informed consent or comply with subsequent follow-up requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200090
Wu Xin, 86-02133189900 ext. 8613764046908, wuxin_fc@fudan.edu.cn
About this study
Official title: Exploratory Study on Near-Infrared Fluorescence Imaging Technology Combined with Indocyanine Green Guided Cervical Cancer Lymph Node Metastasis
The goal of this exploratory study is to exploring the lymph node metastasis, tumor margin, blood vessels, ureters, and nerve imaging in cervical cancer surgery using near-infrared fluorescence imaging technology combined with indocyanine green, and establishing an artificial intelligence model for predicting lymph node metastasis of cervical cancer to guide the advancement of refined surgical procedures.And the focus of this study is to investigate the situation of pelvic lymph node metastasis.The sole medication used in this experiment is the fluorescent contrast agent that has been clinically used for over 40 years - Indocyanine Green (ICG).Subsequent pathology results after the surgery will be used as the gold standard to determine the detection rate of lymph node metastasis and the accuracy of the complete resection rate of the surgical margin in cervical cancer.The researchers will also follow up on the quality of life of patients after the surgery.
The main question it aims to answer is:
can artificial intelligence multimodal fusion prediction models improve the accuracy of preoperative diagnosis of pelvic lymph node metastasis in cervical cancer? The researchers compared the AI multimodal fusion prediction model with traditional imaging physician assessments to see if the prediction model could yield more accurate lymph node metastasis determinations. Participants will undergo pelvic MRI after pathologically confirming a diagnosis of cervical cancer, and the results will be used to determine pelvic lymph node metastasis status by the predictive model and the imaging physician, respectively. Subsequent pathology results after surgical lymph node clearance will be used as the gold standard to determine the accuracy of the two preoperative lymph node diagnostic modalities.
- Conditions
- Uterine Cervical Neoplasms
- Being tested
- Indocyanine green (ICG) injection for intraoperative lymph node 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 green (ICG) injection for intraoperative lymph node imagingDrug
Injection is performed at the 3 o'clock and 9 o'clock positions of the cervix, with 1 ml on each side, for a total dose of 2 ml. Injection depth: The tracer is injected into the superficial (2 mm) and deep (1 cm) layers, with the superficial injection performed first, followed by the deep injection.
| Study group | Role | What they receive |
|---|---|---|
| Lymph node metastasis fluorescence imaging group | Experimental | Not described Receives: Drug: Indocyanine green (ICG) injection for intraoperative lymph node imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity of lymph node metastasis fluorescence imaging（Signal-to-Background Ratio）.
Measured: The time frame was from subject enrollment until surgical pathology results were obtained. The time between subject enrollment and the availability of surgical pathology results was approximately 1 to 1.5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Jan 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840418
- Sponsor's protocol ID
- FUOBGY-2024-224
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on Near-Infrared Fluorescence Imaging Technology Combined with Indocyanine Green Guided Cervical Cancer Lymph Node Metastasis
- ClinicalTrials.gov ID
- NCT06840418
- Acronym / sponsor ID
- FUOBGY-2024-224
- Conditions
- Uterine Cervical Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Feb 2025 (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.
The goal of this exploratory study is to exploring the lymph node metastasis, tumor margin, blood vessels, ureters, and nerve imaging in cervical cancer surgery using near-infrared fluorescence imaging technology combined with indocyanine green, and establishing an artificial intelligence model for predicting lymph node metastasis of cervical cancer to guide the advancement of refined surgical procedures.And the focus of this study is to investigate the situation of pelvic lymph node metastasis.The sole medication used in this experiment is the fluorescent contrast agent that has been clinically used for over 40 years - Indocyanine Green (ICG).Subsequent pathology results after the surgery will be used as the gold standard to determine the detection rate of lymph node metastasis and the accuracy of the complete resection rate of the surgical margin in cervical cancer.The researchers will also follow up on the quality of life of patients after the surgery.
The main question it aims to answer is:
can artificial intelligence multimodal fusion prediction models improve the accuracy of preoperative diagnosis of pelvic lymph node metastasis in cervical cancer? The researchers compared the AI multimodal fusion prediction model with traditional imaging physician assessments to see if the prediction model could yield more accurate lymph node metastasis determinations. Participants will undergo pelvic MRI after pathologically confirming a diagnosis of cervical cancer, and the results will be used to determine pelvic lymph node metastasis status by the predictive model and the imaging physician, respectively. Subsequent pathology results after surgical lymph node clearance will be used as the gold standard to determine the accuracy of the two preoperative lymph node diagnostic modalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymph node metastasis fluorescence imaging group | Experimental | Drug: Indocyanine green (ICG) injection for intraoperative lymph node imaging |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with primary cervical cancer stages I to III, with no restrictions on pathological type.
- Age ≥18 years old and ≤75 years old.
- Patients who have undergone radical hysterectomy/modified radical hysterectomy (referring to the Q-M surgery classification, with surgical methods of type B and type C) + pelvic lymph node dissection.
- Patients with complete preoperative clinical and postoperative pathological data.
- Normal liver and kidney function and within the normal range of blood routine tests (specific details are as follows): Hemoglobin >60 g/L; Platelets >70 * 10^9/L; White blood cells >3 * 10^9/L; Creatinine <50 mg/dL; Abnormal liver enzyme indicators ≤3 items; The highest value of liver enzymes does not exceed three times the corresponding normal value.
Key exclusion criteria (6 listed)
- Patients with allergies to ICG or iodine. Individuals with contraindications to various surgeries who cannot undergo surgery.
- Patients with recurrent cervical cancer.
- Patients who have participated in other clinical trials within the past 3 months.
- Other conditions deemed unsuitable for inclusion in this study by the 5.investigator, or patients with other underlying diseases that may confound the study results.
- 6.Patients who are assessed preoperatively as having systemic and organ conditions that are unlikely to tolerate surgery.
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 green (ICG) injection for intraoperative lymph node imagingInjection is performed at the 3 o'clock and 9 o'clock positions of the cervix, with 1 ml on each side, for a total dose of 2 ml. Injection depth: The tracer is injected into the superficial (2 mm) and deep (1 cm) layers, with the superficial injection performed first, followed by the deep injection. | Drug | Lymph node metastasis fluorescence imaging group |
Primary outcome
The sensitivity of lymph node metastasis fluorescence imaging（Signal-to-Background Ratio）.
Time frame: The time frame was from subject enrollment until surgical pathology results were obtained. The time between subject enrollment and the availability of surgical pathology results was approximately 1 to 1.5 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Uterine Cervical Neoplasms
RecruitingPhase 2
Triage of Advanced Cervical Cancer Through Immunotherapy Induction (TRACTION)
Metastatic Cancer, Cervical Cancer
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
Active, not recruitingPhase 2
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)
Ovarian Neoplasms, Endometrial Neoplasms
RecruitingEarly Phase 1
177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors
PDL1 Gene Mutation, Non Small Cell Lung Cancer
Active, not recruitingPhase 1
Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers
Advanced Cancer, Advanced Malignancies
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.
The Obstetrics and Gynecology Hospital of Fudan University
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine green (ICG) injection for intraoperative lymph node imaging in people with Uterine Cervical Neoplasms, run by Obstetrics & Gynecology Hospital of Fudan 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 10 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 21 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity of lymph node metastasis fluorescence imaging（Signal-to-Background Ratio）. (time frame: The time frame was from subject enrollment until surgical pathology results were obtained. The time between subject enrollment and the availability of surgical pathology results was approximately 1 to 1.5 months.). 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 21 Feb 2025.