NCT06673511

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Jan 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Jan 2025Jun 2027

First Submitted

Initial submission to the registry

October 14, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

November 21, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

October 14, 2024

Last Update Submit

November 19, 2024

Conditions

Epithelial Ovarian CancerSentinel Lymph Node Detection

Outcome Measures

Primary Outcomes (1)

  • 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.

    three years

Secondary Outcomes (1)

  • OS

    three years

Study Arms (2)

Lymph node developing group

EXPERIMENTAL

After injecting IGG intraoperatively, the developing lymph nodes and systemic lymph nodes are resected.

Procedure: Lymph node visualization

lymph node non-developing group

EXPERIMENTAL

After injecting IGG intraoperatively, the developing lymph nodes and systemic lymph nodes are resected

Procedure: No visualization of lymph nodes

Interventions

Lymph node visualizationPROCEDURE

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.

Lymph node developing group
No visualization of lymph nodesPROCEDURE

Resect the systematic lymph nodes. Conduct postoperative follow-up and pay attention to the relevant indicators of the patient after surgery.

lymph node non-developing group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

Zhen / Shen, MMed

CONTACT

+86551-13956005872doctorsz0311@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2024

First Posted

November 5, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

November 21, 2024

Record last verified: 2024-10