Sentinel lymph node assessment in ovarian cancer. Lymphatic mapping with two tracers and intraoperative lymphoscintigraphy.

Phase 1

• Conditions: Sentinel lymph node in ovarian cancer; MedDRA version: 20.0Level: LLTClassification code 10072873Term: Sentinel lymph node mappingSystem Organ Class: 100000004848; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2020-005546-42-ES
• Lead Sponsor: Fundacio Clinic per a la Recerca Biomedica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-05
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

- -Patients with adnexal mass of high suspicion of malignancy requiring intra-operative biopsy.
-Patients with diagnostic of epithelian ovarian cancer (EOC) in initial stage requiring lymphoid mapping and lymphadenectomy
- Lack of radiologic retroperitoneal or metastacic disease
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 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 62

Exclusion Criteria

Age <18
- Pregnancy or breastfeeding
- EOC figo stages III or IV.
- Biopsy unavailability.
- Prior vascular surgery, lymphadenectomy or radiotherapy in the region
- Non-surgical patient.
- Known allergy to study drugs

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Identification of sentinel lymph node in ovarian cancer and assessment of its diagnostic effectiveness in lymphoid mapping using two tracers and intra operative scintigraphy;Secondary Objective: Lymph mapping in initial stage ovarian cancer patients for each tracer (99mTc-albumin nanocolloid and ICG). <br>Usefulness of intra-operative scintygraphy gamma-detecting probe and NIR camera in ovalian lymph mapping. <br><br>- Rate of sentinel node identification with each tracer. <br>- False negative rate in metastatic patients. <br>- micrometastasis detection rate .;Primary end point(s): Existencia de drenaje linfático, definida como la visualización, como mínimo, de un ganglio linfático a nivel pélvico o paraórtico;Timepoint(s) of evaluation of this end point: 1 hour

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time to drainage visualization: minutes since injection until intra-node observation. <br>o Assessment of drainage path: pelvic, paraortic, both.<br> o Number of sentinel nodes with biopsy<br>o Surgical/post-surgical complications<br>o duration of admission (days)<br>o FIGO stage surgical;Timepoint(s) of evaluation of this end point: 30 days