Feasibility of performing the Sentinel Node technique in patients with early stage ovarian cancer.

Phase 1

• Conditions: Early stage ovarian cancer; MedDRA version: 20.0 Level: LLT Classification code 10052111 Term: Ovarian surgery System Organ Class: 100000004865; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-003683-12-ES
• Lead Sponsor: INSTITUTO DE INVESTIGACIÓN SANITARIA LA FE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-21
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

· Informed consent signed prior to performing any procedure related to the clinical trial.
· Women over 18 years old at the time of inclusion.
· Patients with anatomopathological diagnosis of malignant ovarian tumor in a deferred study, proposals for staging surgery or patients with suspicious of malignant tumor who are going to be subjected to exploratory laparotomy and operative biopsy, and in case of positivity, staging surgery will be performed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

· Non-obtaining / informed consent withdrawal.
· Benign result in extemporaneous study.
· Previous history of vascular surgery in the aorta, cava or pelvic vessels.
· Previous pelvic or paraaortic lymphadenectomy.
· Previous lymphoma.
· Previous abdominopelvic tumor.
· Previous allergic reaction to indocyanine green.
· Pregnancy / Breastfeeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To describe the feasibility of performing the Sentinel Node technique (Sentinel Node detection rate) in patients with previous ovarian surgery by injecting the tracer into the stump of the infundibular-pelvic ligament and uterus-ovarian ligament;Secondary Objective: Technique performance rate, anatomical location of the sentinel node (s), number of sentinel nodes detected;Primary end point(s): Sentinel Node detection rate;Timepoint(s) of evaluation of this end point: Day 0 (intraoperative)

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Day 0 and day 30;Secondary end point(s): Tumor size, tumor location, injection site, injection-detection interval, number of lymph nodes detected (with Tc99, with, indocyanine green or both), anatomical location of the sentinel, number of detected sentinel nodes, intensity of the radioactive signal of the gamma -camera, surgical procedure performed, histological type, degree of differentiation, binary classification, histological result of the sentinel lymph node and the rest of lymph nodes obtained in lymphadenectomy and FIGO stage