NCT06673511Not yet recruiting
The Application of Sentinel Lymph Node Mapping Technique in the Surgery of Early Epithelial Ovarian Cancer
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
Source: ClinicalTrials.gov · Last updated 21 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 246 (estimated)
- First submitted
- 14 Oct 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Anhui Provincial Hospital
- Diseases
- Ovarian cancer
- NCT number
- NCT06673511
What you commit to
- Study type: Interventional
- Planned participants: 246
- From 1 Jan 2025 to the primary completion date, 30 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Advanced epithelial ovarian cancer or retroperitoneal lymph node metastasis evaluated by preoperative imaging (enhanced CT and/or magnetic resonance scanning).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.