Clinical trial · Interventional
Sentinel Node Detection in Ovarian Cancer
Sentinel Node in Ovarian Cancer: SONAR-2
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low detection of the SN in patients included so far (n=11)
Summary
Brief summary (as posted)
Recently the investigators have shown that the SN procedure performed through the injection of tracers into the ovarian ligaments is feasible and promising in patients with clinical early stage ovarian cancer (OC). Injection of radioactive tracers resulted in the identification of SNs in all 21 patients. Before a multicentre prospective trial can be initiated, still some questions have to be answered, especially if a SN procedure still is feasable in patients with OC through injection of the tracers in the ovarian ligaments, when the ovarian tumour has already been resected, either during the same surgical procedure (ovarian tumour resected for frozen section with a malignancy as result) or at a second surgical procedure to complete the staging procedure (by laparotomy or laparoscopy).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Sentinel Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Injection of radioactive tracer combined with Patent Blue | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sentinel node procedure.
- description
- Intervention: injection of blue dye and radioactive tracer (99mTc-nanocolloid or Nanocoll) in remains of the ovarian ligaments.
- interventionNames
- Procedure: Injection of radioactive tracer combined with Patent Blue
Primary outcomes (1)
- measure
- Number of patients (%) in which sentinel node(s) are detected after injection of blue dye and tracer in the ovarian ligaments.
- timeFrame
- During the surgical procedure
Secondary outcomes (1)
- measure
- Number of blue colorized sentinel nodes (%) 15, 30, 45, and 60 minutes after injection.
- timeFrame
- During the surgical procedure
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a high suspicion of a malignant ovarian tumour planned for exploratory laparotomy. Only when a malignancy is confirmed by frozen section, the SNs will be removed prior to proceeding with a complete staging procedure. * Patients in whom the ovarian malignant tumour has already been resected and a second surgical procedure is planned to complete the staging procedure including lymph nodes. * Mentally competent to give informed consent. Exclusion Criteria: * Previous vascular surgery of the aorta, caval vein, and/or iliac vessels. * Previous lymphadenectomy of lymph node sampling in the iliac or para-aortal region. * History of a malignant lymphoma. * History of a malignant tumour in the abdominal cavity. * Previous allergic reaction to blue dye. * Pregnant or lactating patients. * An allergy for human albumin.
References
Publications (2)
- RESULTKleppe M, Brans B, Van Gorp T, Slangen BF, Kruse AJ, Pooters IN, Lotz MG, Van de Vijver KK, Kruitwagen RF. The detection of sentinel nodes in ovarian cancer: a feasibility study. J Nucl Med. 2014 Nov;55(11):1799-804. doi: 10.2967/jnumed.114.144329. Epub 2014 Oct 20. PMID 25332439
- DERIVEDLaven P, Kruitwagen R, Zusterzeel P, Slangen B, van Gorp T, van der Pol J, Lambrechts S. Sentinel lymph node identification in early stage ovarian cancer: is it still possible after prior tumor resection? J Ovarian Res. 2021 Oct 13;14(1):132. doi: 10.1186/s13048-021-00887-w. PMID 34645514