Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II)
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Negative predictive value of the sentinel lymph node technique.
Study Overview
Brief Summary
This clinical trial investigates the sentinel lymph node (SLN) technique as a less invasive alternative to conventional lymphadenectomy in patients with early-stage ovarian cancer. The primary objective is to evaluate the effectiveness, safety, and diagnostic accuracy of the SLN approach in detecting lymphatic metastases. By assessing its negative predictive value, the study aims to determine whether the SLN technique can reliably replace systematic pelvic and paraaortic lymphadenectomy. If successful, this technique could minimize surgical morbidity, shorten hospitalization stays, and lower complication rates, ultimately improving patient outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Women >18, with confirmed early-stage ovarian cancer, undergoing staging surgery.
A 0.2 ml (27 mBq) dose of 99mTc and 0.5 ml (1.25 mg/ml) of ICG is injected subperitoneally in the dorsal or ventral side of the pelvic infundibulum stump, and 0.2 ml (27 mBq) of 99mTc and 1 ml (1.25 mg/ml) of ICG intracervically. Sentinel nodes are located using the auditory signal from the gamma probe and visually via ICG staining with an infrared light system. After 30 minutes, all identified nodes are removed. Deferred histology applies ultra-staging for negative or micrometastatic nodes.
Intervention: Sentinel Node Technique (Procedure)
Outcomes
Primary Outcomes
Negative predictive value of the sentinel lymph node technique.
Time Frame: Postoperative (30 days +/- 10 days)
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.
Secondary Outcomes
- Determine Sentinel Lymph Node Procedure Rate(Intraoperative and postoperative (30 days +/- 10 days).)
- Concordance of Sentinel Lymph Node Technique vs. Lymphadenectomy(Postoperative (30 days +/- 10 days).)
- Characterize Sentinel Lymph Node Technique vs. Lymphadenectomy for Metastasis Detection(Intraoperative and postoperative (30 days +/- 10 days).)
- Sample Characterization(Baseline visit and Intraoperative)
- Characterize Sentinel Lymph Node Technique Based On Site of Drug Injection(Intraoperative and postoperative (30 days +/- 10 days).)
- Determine the rate of "empty" sentinel lymph node detection.(Postoperative (30 days +/- 10 days).)
- Determine Pelvic and/or Paraaortic Sentinel Lymph Node Detection Rate(Intraoperative and postoperative (30 days +/- 10 days).)
- Identify the anatomical location of the sentinel lymph nodes.(Intraoperative and postoperative (30 days +/- 10 days).)
- Determine the number of detected lymph nodes.(Intraoperative and postoperative (30 days +/- 10 days).)
- Rate of overstaging with ultrastaging.(Postoperative (30 days +/- 10 days).)
- Complications related to the sentinel lymph node technique(Intraoperative and postoperative (30 days +/- 10 days).)
- Complications related to lymphadenectomy.(Intraoperative and postoperative (30 days +/- 10 days).)