Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II)

Launched by INSTITUTO DE INVESTIGACION SANITARIA LA FE · Apr 30, 2025

Keywords

ClinConnect Summary

The SENTOV II clinical trial is studying a new method called the sentinel lymph node (SLN) technique for women with early-stage ovarian cancer. This technique is being tested as a less invasive option compared to traditional surgery, which involves removing many lymph nodes to check for cancer spread. The goal is to see if the SLN technique can effectively and safely identify whether the cancer has spread to the lymph nodes, potentially leading to shorter hospital stays and fewer complications for patients.

To participate in this trial, women must be at least 18 years old and have a confirmed diagnosis of early-stage ovarian cancer or be suspected of having it. They should also be scheduled for surgery related to their cancer. However, some women may not be eligible if they have certain medical histories, such as previous lymphatic surgeries or specific allergies. If women decide to join the trial, they can expect close monitoring and support throughout the process, helping to ensure their safety and well-being as researchers gather important information about this new technique.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent prior to the performance of any procedure related to the clinical trial.
• • Female, 18 years of age or older at the time of inclusion.
• • Patients with a histopathological diagnosis of malignant ovarian tumor in a deferred study (any epithelial histology), in apparent early stage FIGO I-II, proposed for staging surgery, or patients with suspected malignant ovarian tumor in apparent early stage FIGO I-II, who will undergo exploratory laparotomy and operative biopsy, and if positive, will undergo staging surgery.
• Exclusion Criteria:
• • Failure to obtain informed consent or revocation of informed consent.
• • Under 18 years of age at the time of inclusion.
• • Previous history of vascular surgery on the aorta, vena cava, or pelvic vessels.
• • Previous pelvic or paraaortic lymphatic surgery.
• • Previous lymphoma.
• • Previous abdomino-pelvic tumor.
• • Previous allergy to Tc99 or ICG.
• • Pregnancy/Breastfeeding.
• • Patients who have signed informed consent but do not meet all inclusion criteria and none of the exclusion criteria will be considered as selection failures.