Validation of Sentinel Lymph Node Technique in Early-Stage Ovarian Cancer Using Pertechnetate (99mTc) Sodium, Human Serum Albumin, and Indocyanine Green

The primary objective of this study is to determine the **negative predictive value** of the sentinel lymph node technique for detecting lymph node metastases in early-stage ovarian cancer, using pelvic/aortic lymphadenectomy as the Gold Standard. This is clinically relevant as it aims to validate a less invasive method for assessing lymph node involvement, potentially reducing the need for extensive surgical procedures and associated morbidities.

Secondary objectives include:

• Evaluating the degree of concordance between the sentinel lymph node technique and pelvic/aortic lymphadenectomy in terms of sensitivity, specificity, positive predictive value, and diagnostic accuracy.
• Characterizing the sentinel lymph node technique based on various parameters such as sensitivity, specificity, predictive values, likelihood ratios, and effectiveness.
• Characterizing the sample through baseline characteristics, medical history, tumor markers, intraoperative findings, surgical procedures, and immediate admission data.
• Determining the sentinel lymph node procedure rate and the rate of "empty" sentinel lymph node detection.
• Determining the detection rate of pelvic and/or paraaortic sentinel lymph nodes and identifying their anatomical location.
• Determining the number of detected lymph nodes and the rate of overstaging with ultrastaging.
• Assessing complications related to the sentinel lymph node technique and lymphadenectomy.

The clinical trial involves a study population exclusively comprising **female** participants aged 18 years and older. The trial focuses on individuals diagnosed with **ovarian cancer**, specifically those in the apparent early stages FIGO I-II, either confirmed through an anatomopathological diagnosis or suspected and undergoing exploratory laparotomy. Participants are required to have signed informed consent prior to any trial-related procedures. The trial does not include male subjects or vulnerable populations. The sponsor has not provided information regarding the total number of participants. Lifestyle factors such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the **sentinel lymph node** technique in patients with early-stage **ovarian cancer**. This is a phase III, randomized, double-blind, controlled trial aimed at determining the negative predictive value of the sentinel lymph node technique for detecting lymph node metastases, using pelvic/aortic lymphadenectomy as the gold standard. The trial is expected to commence recruitment on June 2, 2025, and conclude by June 2, 2028. Participants will be involved in the study for a maximum treatment period of one day, with the primary endpoint being the negative predictive value of the sentinel lymph node technique.

The study will include several visits, starting with a screening visit to confirm eligibility based on criteria such as age, diagnosis of malignant ovarian tumor, and consent. The inclusion criteria require participants to be female, 18 years or older, with a diagnosis of malignant ovarian tumor in an apparent early stage FIGO I-II, or with suspected malignant ovarian tumor in the same stage. The trial will exclude any participants who do not meet these criteria. Following the screening, participants will undergo a series of study visits, including the administration of the investigational products, which include **pertechnetate (99mtc) sodium**, **human serum albumin**, and **indocyanine green**, all administered via peritumoral injection.

Follow-up visits will be scheduled to monitor the participants' response to the treatment and to collect data on secondary endpoints such as tumor size, location, and the number of detected sentinel lymph nodes. The end-of-study visit will involve a comprehensive assessment to evaluate the outcomes of the trial. Participants may be withdrawn from the study if they experience significant adverse effects, fail to comply with the study protocol, or withdraw consent. The trial's design ensures rigorous monitoring and data collection to achieve its objectives while maintaining participant safety and data integrity.

The clinical trial involves the administration of **Pertechnetate (99mTc) Sodium**, which is provided as a solution for injection. This experimental medication is administered peritumorally, with a maximum daily and total dose of 200 MBq (megabecquerels). The treatment period is limited to one day. The active substance, Pertechnetate (99mTc) Sodium, is of chemical origin and is utilized in the study to evaluate its efficacy in the sentinel lymph node technique for early-stage ovarian cancer.

**Human Serum Albumin** is also used in this trial, formulated as a suspension for injection. It is administered peritumorally, with a maximum daily and total dose of 200 MBq. The treatment duration is restricted to one day. Human Serum Albumin is a structurally diverse substance derived from blood and plays a role in the study as part of the experimental treatment regimen.

Additionally, **Indocyanine Green** is employed in the trial as a solution for injection. This diagnostic dye is administered peritumorally, with a maximum daily and total dose of 5 mg/kg. The treatment period is confined to one day. Indocyanine Green, of chemical origin, is used to enhance the visualization of sentinel lymph nodes during the procedure.

All medications are administered peritumorally, and participant compliance is monitored throughout the study. The trial aims to validate the sentinel lymph node technique in detecting lymph node metastases in early-stage ovarian cancer, using pelvic/aortic lymphadenectomy as the gold standard.

The efficacy of the clinical trial titled "Validation of the Sentinel Lymph Node Technique in Early-Stage Ovarian Cancer (SENTOV II)" will be assessed primarily through the **negative predictive value** of the sentinel lymph node technique for detecting lymph node metastases. This will be compared against the Gold Standard of pelvic/aortic lymphadenectomy. Secondary endpoints include a comprehensive set of parameters such as tumor size, tumor location, injection site, type of tracer used, injection-detection interval, detection method, anatomical location of the sentinel node, number of detected sentinel lymph nodes, number of detected lymph nodes, histological type, degree of differentiation, lymphovascular invasion, ultrastaging, binary classification, histological result, FIGO stage, surgical procedure performed, and intraoperative complications.