Sentinel node detection with 99Tc albumin nanocolloid and indocianine green (ICG) in patients with epithelial ovarian cancer in early stages. Pilot study.

Phase 1

Recruiting

• Conditions: Epithelial ovarian cancer in early stages.; MedDRA version: 20.0Level: PTClassification code: 10061328Term: Ovarian epithelial cancer Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]; Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

• Registration Number: CTIS2023-505667-37-00
• Lead Sponsor: Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 62

Inclusion Criteria

1. Patients with adnexal mass diagnosed with high suspicion of malignancy that will undergo intraoperative biopsy or patients with already diagnosed epithelial cancer in early stages in a previous surgery and confirmed by pathology with complete stadification indicated. 2. Absence of retroperitoneal ganglionary affectation and metastatic disease evaluated by preoperative imaging techniques. 3. Signing of informed consent by the patient or relative in charge. 4. Women with childbearing potential must compromise to use highly effective contraceptive methods (partner vasectomized, sexual abstinence) until the end of the study (last study visit).

Exclusion Criteria

1. Patients <18 years 2. Pregnancy or breastfeeding 3. Epithelial ovarian tumors stage FIGO III or IV. 4. Impossibility to obtain a biopsy from the tumor. 5. History of previous vascular surgery (cava vein, aorta, iliac blood vessels) or radiotherapy in pelvic or para-aortic area. 6. Sentinel lymph node biopsy will not be performed if intraoperative histologic study shows a benign ovarian tumor, low malignancy potential tumor or expansive mucinous histology. 7. Patient not able to undergo surgery 8. Hypersensitivity to active principle, to sodium iodide or iodine allergy. 9. Patients with clinic hyperthyroidism, thyroid autonomous adenomas or focal and diffused autonomous alteration of thyroid gland

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the diagnostic efficiency of both tracers in sentinel lymph node detection;Secondary Objective: To evaluate the diagnostic precision for the detection of sentinel lymph node in epithelial ovarian cancer in early stages., To evaluate the lymphatic map in patients with epithelial ovarian cancer in early stages for each of the tracers (99Tc albumin nanocolloid and ICG), To evaluate the anatomic distribution of 99mTC draining in the group of total patients included., To evaluate the performance of intraoperative detector gamma probe and NIR camera in the display of ovarian lymphatic map., To learn the anatomic distribution of sentinel lymph node and metastases., To evaluate if sentinel lymph node ultrastadification improves micrometastases detection compared to conventional histology., To evaluate the complications associated with each technique.;Primary end point(s): Global detection rate of sentinel lymph node in patients having received both tracers.