The Application of Sentinel Lymph Node Mapping Technique in the Surgery of Early Epithelial Ovarian Cancer

November 19, 2024 updated by: Anhui Provincial Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
246

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. Age between 18 and 75 years old (≥18 and ≤75).
  3. ECOG score: 0 - 1.
  4. 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.
  5. No fertility requirement.
  6. Have signed the informed consent form.

Exclusion Criteria:

  1. Advanced epithelial ovarian cancer or retroperitoneal lymph node metastasis evaluated by preoperative imaging (enhanced CT and/or magnetic resonance scanning).
  2. Previous history of resection or sampling of para-aortic and/or iliac vascular lymph nodes.
  3. Previous history of abdominal aorta and/or iliac vascular surgery.
  4. Previous allergy to indocyanine green or iodine.
  5. Previous history of abdominal radiotherapy.
  6. Pregnant and lactating patients.
  7. Those who refuse to sign the informed consent form.
  8. Those who are considered by the investigator as inappropriate to participate in this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lymph node developing group
After injecting IGG intraoperatively, the developing lymph nodes and systemic lymph nodes are resected.
Procedure: Lymph node visualization
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.
Experimental: lymph node non-developing group
After injecting IGG intraoperatively, the developing lymph nodes and systemic lymph nodes are resected
Procedure: No visualization of lymph nodes
Resect the systematic lymph nodes. Conduct postoperative follow-up and pay attention to the relevant indicators of the patient after surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
three years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
OS
Time Frame: three years
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.
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anhui Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Shen zhen 2024-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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