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VALIDATION OF THE SENTINEL LYMPH NODE TECHNIQUE IN EARLY-STAGE OVARIAN CANCER (SENTOV II)
EU CTIS ID: 2024-520189-67-00
What this study is testing
To determine the negative predictive value of the sentinel lymph node technique for detecting lymph node metastases, using pelvic/aortic lymphadenectomy as the Gold Standard.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 an anatomopathological 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.
You likely can't join if
- 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.
See the full eligibility 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 an anatomopathological 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.