TheranosticTrials.org

Clinical Trial · NCT05937620

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

Overview

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

Sponsor

Unknown Organization

Phase

N/A

Contacts

Aureli Torné, Physician (PRINCIPAL_INVESTIGATOR)

Berta Diaz-Feijoo, Physician (PRINCIPAL_INVESTIGATOR)

Laura Burunat, Graduate (CONTACT)

burunat@recerca.clinic.cat

0034 932275400

ClinicalTrials.gov

NCT05937620

Drug / Compound

Albumin Nanocolloid

Isotope(s):
Target(s):
  • No Explicit Target
Ligand Class: Small Molecules

Eligibility

Inclusion

  • * 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.
  • 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).
  • Absence of retroperitoneal ganglionary affectation and metastatic disease evaluated by preoperative imaging techniques.

Exclusion

  • 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.
  • * Patients \<18 years
  • Pregnancy or breastfeeding