SEntinel Lymph node in EarLY ovarian cancer: the SELLY protocol - SELLY

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 176 人开始时间: 2021年8月31日最近更新: 2021年9月7日

试验速览

暂无简介。

•1. Diagnosis of EOC macroscopically limited to the ovaries or the pelvis (surgical stage I-II)
•2. Surgical staging
•3. Age between 18 and 80
•4. Performance Status (ECOG) <= 2, an adequate respiratory, hepatic, cardiac, bone marrow, liver and renal function (Creatinine Clearance > 60 mL/min according to Cockroft formula)
•5. Negative preoperative CT scan imaging for positive nodes (defined as lymph modes < 1cm in their larger axis).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 56

•1.FIGO stages III B, III C or IV
•2.Mucinous histology
•3.Previous surgery of the aorta, caval vein, and/or iliac vessels
•4.Previous lymphadenectomy or lymph node sampling in the iliac or para-aortic region that could change the ovarian lymphatic drainage
•5.Hepatic dysfunction defined as a Model for End-Stage Liver Disease score of 10 or greater, renal dysfunction defined as serum creatinine of 2.0 mg/dL or greater
•6.Usage of any other tracer but ICG
•7.History of allergy to ICG, iodine, iodine dyes, isosulfan blue, or triphenylmethane
•8.History of a malignant lymphoma
•9.History of a malignant tumor in the abdominal cavity
•10.Concomitant other malignancies
•11.Previous abdominal radiation therapy
•12.Pregnancy or lactation
•13.Refusal to provide written informed consent

发起方

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE