Ireland
--:--IST
Recruiting Not applicable

Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epithelial Ovarian Cancer

NCT05937620 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2023-09-01
Last updated
2026-02-09

Condition(s) studied

Ovarian Epithelial Cancer

Investigational drug(s) / intervention(s)

99mTC nanocolloid albumin injectionICG injection

99mTC nanocolloid albumin injection: All patients will receive an injection of both tracers in order to detect the sentinel lymph node

ICG injection: All patients will receive an injection of both tracers in order to detect the sentinel lymph node

Study summary

Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 staging indicated. * Absence of retroperitoneal ganglionary affectation and metastatic disease evaluated by preoperative imaging techniques. * Signing of informed consent by the patient or relative in charge. * 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: * Patients \<18 years * Pregnancy or breastfeeding * Epithelial ovarian tumors stage FIGO III or IV. * Impossibility to obtain a biopsy from the tumor. * History of previous vascular surgery (cava vein, aorta, iliac blood vessels) or radiotherapy in pelvic or para-aortic area. * 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. * Patient not able to undergo surgery. * Hypersensitivity to active principle, to sodium iodide or iodine allergy. * Patients with clinic hyperthyroidism, thyroid autonomous adenomas or focal and diffused autonomous alteration of thyroid gland

Primary outcome measure(s)

  • Evaluation of the diagnostic efficiency of both tracers in sentinel lymph node detection — Through study completion (an average of 36 months)
    Global detection rate of sentinel lymph node in patients having received both tracers.

Trial sites (1)

FacilityCityRegionStatus
Laura Burunat Barcelona Catalonia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05937620 on ClinicalTrials.gov ↗ ← All trials in Spain