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

Sentinel node in ovarian cáncer: tailoring clinical feasibility

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003683-12-ES

Enrollment

Registered

2017-12-21

Start date

2018-01-23

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early stage ovarian cancer MedDRA version: 20.0 Level: LLT Classification code 10052111 Term: Ovarian surgery System Organ Class: 100000004865

Interventions

Trade Name: 99m-Technetium albumin nanocolloid Product Name: 99m-Technetium albumin nanocolloid Pharmaceutical Form: Lyophilisate for solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Primary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

Spain

Contacts

Public ContactMARIA CORTELL

INSTITUTO DE INVESTIGACIÓN SANITARIA LA FE

investigacion_clinica@iislafe.es0034961246611

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026