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

Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer0 个研究点目标入组 62 人开始时间: 2023年6月19日最近更新: 2024年7月22日

适应症

试验速览

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•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).

•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

发起方

Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer