Epithelial Ovarian CancerNCT06673511
The Application of Sentinel Lymph Node Mapping Technique in the Surgery of Early Epithelial Ovarian Cancer
A study testing Lymph node visualization and No visualization of lymph nodes in people with Epithelial Ovarian Cancer and Sentinel Lymph Node Detection, run by Anhui Provincial Hospital.
Trial summary
This study is a single-arm, open, multicenter, exploratory clinical study to evaluate the feasibility, sensitivity, and specificity of sentinel lymph node (SLN) mapping technology in the population with early epithelial ovarian cancer in China. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Sentinel Lymph Node Detection
- What is being tested?
- Lymph node visualization and No visualization of lymph nodes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 30 Jun 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
- Epithelial ovarian cancer evaluated as stage I-II by preoperative imaging (enhanced CT and/or magnetic resonance scanning), without retroperitoneal lymph node enlargement or with lymph node enlargement having a short diameter less than 1 cm.
- Age between 18 and 75 years old (≥18 and ≤75).
- ECOG score: 0 - 1.
- Patients with appropriate bone marrow hematopoiesis function, renal function and liver function: white blood cell count \> 3.0 x 109 cells/L; platelet count \> 100 x 109/L; creatinine \< 180 μmol/L; bilirubin \< 1.5 times normal; aspartate aminotransferase/alanine aminotransferase \< 3 times normal.
- No fertility requirement.
- Have signed the informed consent form.
Who cannot join
- Advanced epithelial ovarian cancer or retroperitoneal lymph node metastasis evaluated by preoperative imaging (enhanced CT and/or magnetic resonance scanning).
- Previous history of resection or sampling of para-aortic and/or iliac vascular lymph nodes.
- Previous history of abdominal aorta and/or iliac vascular surgery.
- Previous allergy to indocyanine green or iodine.
- Previous history of abdominal radiotherapy.
- Pregnant and lactating patients.
- Those who refuse to sign the informed consent form.
- Those who are considered by the investigator as inappropriate to participate in this trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm, Open, Multicenter, Exploratory Clinical Study on the Application of Sentinel Lymph Node Mapping Mechnique in the Surgery of Early Epithelial Ovarian Cancer
This study is a single-arm, open, multicenter, exploratory clinical study to evaluate the feasibility, sensitivity, and specificity of sentinel lymph node (SLN) mapping technology in the population with early epithelial ovarian cancer in China. Patients with stage I-II epithelial ovarian cancer evaluated by preoperative imaging (enhanced CT and/or magnetic resonance scanning) are selected as the study population. The feasibility and value of SLN mapping technology in early epithelial ovarian cancer are explored through the location and number of sentinel lymph nodes, lymph node metastasis rate, 3-year disease-free survival rate, and the incidence of postoperative lower limb edema. The study plans to recruit 246 subjects. All subjects will receive study treatment after signing the informed consent form and passing the screening.
Read the detailed description
This clinical study is an evaluation of surgical method improvement. The standard surgical procedure includes: selecting patients who meet the inclusion criteria, completing preoperative examinations, having thorough preoperative communication, determining laparoscopic surgery and open surgery according to the patient\'s condition and examinations, mainly using open surgery and strictly screening laparoscopic surgery; carefully exploring the pelvic and abdominal peritoneum and the surface of abdominal organs during the operation, evaluating whether there is lymph node enlargement in the retroperitoneum, taking ascites or peritoneal lavage fluid, after removing the patient\'s adnexa, sending it for rapid pathology. After the pathology is confirmed to be epithelial cancer, select a fine needle to inject 2 ml of ICG (1.25 mg/ml) respectively into the residual end of the suspensory ligament and proper ligament of the affected side. If there are lesions on both adnexa, inject on both sides; open the retroperitoneum and open the peritoneum upward to reach the level of the left renal vein; observe the lymphatic drainage area, separate the lymph and adipose tissue along the blood vessels, and look for the visualized lymph nodes; send the resected visualized lymph nodes for intraoperative rapid pathology; after resecting the visualized sentinel lymph nodes, perform systematic lymph node resection (including the para-aortic lymph nodes below the left renal vein and bilateral pelvic lymph nodes); resect the greater omentum, perform biopsy and/or resect any suspicious lesions, and perform random biopsy of normal peritoneum; resect the total uterus and suture the vaginal stump; conduct postoperative follow-up and collect statistics.
- Being tested
- Lymph node visualization, No visualization of lymph nodes
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymph node visualizationProcedure or surgery
Resect the developing lymph nodes and the systematic lymph nodes. Conduct postoperative follow-up and pay attention to the relevant indicators of the patient after surgery.
No visualization of lymph nodesProcedure or surgery
Resect the systematic lymph nodes. Conduct postoperative follow-up and pay attention to the relevant indicators of the patient after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Lymph node developing group | Experimental | After injecting IGG intraoperatively, the developing lymph nodes and systemic lymph nodes are resected. Receives: Procedure: Lymph node visualization |
| lymph node non-developing group | Experimental | After injecting IGG intraoperatively, the developing lymph nodes and systemic lymph nodes are resected Receives: Procedure: No visualization of lymph nodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-Free Survival (PFS) is defined as the time interval between the patient's diagnosis of gynecological malignancy and the first occurrence of progression of the disease or death from any cause.
Measured: three years
Secondary outcomes (1)
OS
Overall Survival (OS) was defined as the time interval between the patient's diagnosis of gynecologic malignancy and death from any cause or the end of the last follow-up date.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673511
- Sponsor's protocol ID
- Shen zhen 2024-06
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open, Multicenter, Exploratory Clinical Study on the Application of Sentinel Lymph Node Mapping Mechnique in the Surgery of Early Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06673511
- Acronym / sponsor ID
- Shen zhen 2024-06
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Nov 2024 (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.
This study is a single-arm, open, multicenter, exploratory clinical study to evaluate the feasibility, sensitivity, and specificity of sentinel lymph node (SLN) mapping technology in the population with early epithelial ovarian cancer in China. Patients with stage I-II epithelial ovarian cancer evaluated by preoperative imaging (enhanced CT and/or magnetic resonance scanning) are selected as the study population. The feasibility and value of SLN mapping technology in early epithelial ovarian cancer are explored through the location and number of sentinel lymph nodes, lymph node metastasis rate, 3-year disease-free survival rate, and the incidence of postoperative lower limb edema. The study plans to recruit 246 subjects. All subjects will receive study treatment after signing the informed consent form and passing the screening.
Detailed description
This clinical study is an evaluation of surgical method improvement. The standard surgical procedure includes: selecting patients who meet the inclusion criteria, completing preoperative examinations, having thorough preoperative communication, determining laparoscopic surgery and open surgery according to the patient\'s condition and examinations, mainly using open surgery and strictly screening laparoscopic surgery; carefully exploring the pelvic and abdominal peritoneum and the surface of abdominal organs during the operation, evaluating whether there is lymph node enlargement in the retroperitoneum, taking ascites or peritoneal lavage fluid, after removing the patient\'s adnexa, sending it for rapid pathology. After the pathology is confirmed to be epithelial cancer, select a fine needle to inject 2 ml of ICG (1.25 mg/ml) respectively into the residual end of the suspensory ligament and proper ligament of the affected side. If there are lesions on both adnexa, inject on both sides; open the retroperitoneum and open the peritoneum upward to reach the level of the left renal vein; observe the lymphatic drainage area, separate the lymph and adipose tissue along the blood vessels, and look for the visualized lymph nodes; send the resected visualized lymph nodes for intraoperative rapid pathology; after resecting the visualized sentinel lymph nodes, perform systematic lymph node resection (including the para-aortic lymph nodes below the left renal vein and bilateral pelvic lymph nodes); resect the greater omentum, perform biopsy and/or resect any suspicious lesions, and perform random biopsy of normal peritoneum; resect the total uterus and suture the vaginal stump; conduct postoperative follow-up and collect statistics.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lymph node developing group | Experimental | Procedure: Lymph node visualizationAfter injecting IGG intraoperatively, the developing lymph nodes and systemic lymph nodes are resected. |
| lymph node non-developing group | Experimental | Procedure: No visualization of lymph nodesAfter injecting IGG intraoperatively, the developing lymph nodes and systemic lymph nodes are resected |
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)
- Epithelial ovarian cancer evaluated as stage I-II by preoperative imaging (enhanced CT and/or magnetic resonance scanning), without retroperitoneal lymph node enlargement or with lymph node enlargement having a short diameter less than 1 cm.
- Age between 18 and 75 years old (≥18 and ≤75).
- ECOG score: 0 - 1.
- Patients with appropriate bone marrow hematopoiesis function, renal function and liver function: white blood cell count \> 3.0 x 109 cells/L; platelet count \> 100 x 109/L; creatinine \< 180 μmol/L; bilirubin \< 1.5 times normal; aspartate aminotransferase/alanine aminotransferase \< 3 times normal.
- No fertility requirement.
Key exclusion criteria (8 listed)
- Advanced epithelial ovarian cancer or retroperitoneal lymph node metastasis evaluated by preoperative imaging (enhanced CT and/or magnetic resonance scanning).
- Previous history of resection or sampling of para-aortic and/or iliac vascular lymph nodes.
- Previous history of abdominal aorta and/or iliac vascular surgery.
- Previous allergy to indocyanine green or iodine.
- Previous history of abdominal radiotherapy.
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 |
|---|---|---|
| Lymph node visualizationResect the developing lymph nodes and the systematic lymph nodes. Conduct postoperative follow-up and pay attention to the relevant indicators of the patient after surgery. | Procedure or surgery | Lymph node developing group |
| No visualization of lymph nodesResect the systematic lymph nodes. Conduct postoperative follow-up and pay attention to the relevant indicators of the patient after surgery. | Procedure or surgery | lymph node non-developing group |
Primary outcome
PFS
Time frame: three years
Progression-Free Survival (PFS) is defined as the time interval between the patient's diagnosis of gynecological malignancy and the first occurrence of progression of the disease or death from any cause.
1 secondary outcome
OS
Time frame: three years
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 Nov 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Lymph node visualization and No visualization of lymph nodes in people with Epithelial Ovarian Cancer and Sentinel Lymph Node Detection, run by Anhui Provincial Hospital.
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 8 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: opening soon, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Zhen / Shen, MMed (+86551-13956005872, doctorsz0311@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: three years). 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 Nov 2024.