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

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

Recruiting
18 years and older
Female
Phase N/A

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Overview

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

Eligibility

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

Study details
    Ovarian Epithelial Cancer

NCT05937620

Fundacion Clinic per a la Recerca Biomédica

26 February 2026

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