Sentinel Lymph Node in Early Ovarian Cancer (SENTOV)

Instituto de Investigacion Sanitaria La Fe

Status and phase: Completed; Phase 2

Conditions: Ovarian Cancer

Treatments: Other: sentinel node technique

Study type: Interventional

Funder types: Other

Identifiers

NCT03452982

SENTOV

Details and patient eligibility

About

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.

Full description

The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with early stage ovarian cancer.

With this research study it will be evaluated the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Patients with ovarian cancer

Experimental group

Description:

Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection

Treatment:

Other: sentinel node technique