Clinical trial · Interventional
Sentinel Lymph Node in Early Ovarian Cancer
NCT03452982CI-TRIAL-00041192SENTOVcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research study evaluates the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.
Conditions
Conditions (1)
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 Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sentinel node technique | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with ovarian cancer
- description
- Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection
- interventionNames
- Other: sentinel node technique
Primary outcomes (1)
- measure
- Feasibility of performing the sentinel node technique (Detection rate)
- timeFrame
- Intraoperative (day 0)
- description
- The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with previous ovarian surgery injecting the tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.
Secondary outcomes (19)
- measure
- Rate of realization of the technique
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent signed previously to performing any procedure related to the clinical trial. * Patients who are women 18 years of age or older at the moment of the randomization. * Patients with anatomopathological diagnosis of malignant ovarian tumor in a deferred study proposals for staging surgery or patients with suspicious tumor of malignancy who are going to be subjected to exploratory lapaotomy or laparoscopy and operative biopsy, and in the case this is positive, surgery of staging will be performed . Exclusion Criteria: * Informed consent not obtained or withdraw. * Benign result in extemporaneous study * Previous history of vascular surgery in the aorta, cava or pelvic vessels * Previous pelvic or para-aortic lymphadenectomy * Previous lymphoma * Previous abdomino-pelvic tumor * Previous allergic reaction to indocyanine green * Pregnancy / lactation * Severe adherent syndrome
References
Publications (3)
- DERIVEDLago V, Montero B, Lopez S, Padilla-Iserte P, Matute L, Marina T, Gurrea M, Montoliu G, Bello P, Domingo S. Ultrastaging protocol in sentinel lymph node for apparent early stage ovarian cancer. Gynecol Oncol. 2021 May;161(2):408-413. doi: 10.1016/j.ygyno.2021.03.001. Epub 2021 Mar 10. PMID 33712275
- DERIVEDLago V, Bello P, Montero B, Matute L, Padilla-Iserte P, Lopez S, Marina T, Agudelo M, Domingo S. Sentinel lymph node technique in early-stage ovarian cancer (SENTOV): a phase II clinical trial. Int J Gynecol Cancer. 2020 Sep;30(9):1390-1396. doi: 10.1136/ijgc-2020-001289. Epub 2020 May 23. PMID 32448808
- DERIVEDLago V, Bello P, Matute L, Padilla-Iserte P, Marina T, Agudelo M, Domingo S. Sentinel Lymph Node Technique in Apparent Early Ovarian Cancer: Laparoscopic Technique. J Minim Invasive Gynecol. 2020 Jul-Aug;27(5):1019-1020. doi: 10.1016/j.jmig.2019.09.790. Epub 2019 Oct 16. PMID 31628986