Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epithelial Ovarian Cancer (Melisa-II)
Ovarian Epithelial Cancer
About this trial
This is an interventional diagnostic trial for Ovarian Epithelial Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Experimental
Interventional arm
All patients will receive an injection of ICG and an injection of 99mTc nanocolloid albumin