Sentinel Node Detection in Ovarian Cancer

NCT02540551TerminatedPHASE1INTERVENTIONAL

Summary

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).

Key Facts

Lead Sponsor

Maastricht University Medical Center

Enrollment

11

Start Date

2016-01-01

Completion Date

2019-07-01

Study Type

INTERVENTIONAL

Official Title

Sentinel Node in Ovarian Cancer: SONAR-2

Interventions

Injection of radioactive tracer combined with Patent Blue

Conditions

Ovarian NeoplasmsSentinel Node

Eligibility

Age Range

18 Years – 85 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Number of patients (%) in which sentinel node(s) are detected after injection of blue dye and tracer in the ovarian ligaments.

Time frame: During the surgical procedure

Secondary Outcomes

Number of blue colorized sentinel nodes (%) 15, 30, 45, and 60 minutes after injection.

In the investigator's initial feasibility study in which the tracers were injected into the ligaments of the ovary, in only 2 out of 6 patients blue-stained SNs were detected after retroperitoneal exploration. The long interval between the injection of Blue Patent and retroperitoneal exploration of at least 50 min in this study may have caused the blue dye to fade before the surgical procedure.

Time frame: During the surgical procedure

Locations

Maastricht UMC, Dept. Obst&Gyn, Maastricht, Netherlands

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.

Linked Papers

2021-10-13

Sentinel lymph node identification in early stage ovarian cancer: is it still possible after prior tumor resection?

Abstract Objective Sentinel lymph node (SLN) detection in ovarian cancer is feasible when tracers are injected before the pathological ovary is resected. This study aims to investigate whether the SLN identification is also feasible in patients whose ovarian tumor has already been resected with injection of the tracer into the ovarian ligaments stumps, i.e. in the event that a frozen section confirms malignancy. Methods Patients who underwent laparotomy with frozen section confirming an ovarian malignancy, and those who underwent a second staging laparotomy after prior resection of a malignant ovarian mass, were included. Blue dye and a radioactive isotope were injected in the stumps of the ligamentum ovarium proprium and the ligamentum infundibulo-pelvicum. After an interval of at least 15-min, the sentinel node(s) were identified using either the gamma-probe and / or blue dye. Results A total of 11 patients were included in the study, the sentinel node (SLN) procedure was completed in all 11 patients. At least one SLN was identified in 3 patients, resulting in a rather low detection rate of 27,3%. Conclusion In this study we showed that SLN procedure after (previous) resection of the tumor seems inferior to detect sentinel nodes when compared to injection of the tracer in the ovarian ligaments before tumor resection. Trial registration NCT02540551

Linked Investigators

Pim Laven