Visualisation of Indocyanine Green in Primary and Interval Debulking for Ovarian Cancer - VIPIDO

niversity Hospitals Leuven (UZ Leuven)0 个研究点目标入组 40 人开始时间: 2021年7月2日最近更新: 2023年10月9日

适应症

试验速览

暂无简介。

•1.Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
•2.At least 18 years of age.
•3.Advanced stage epithelial ovarian cancer: FIGO stage IIIb, IIIc or IV. (For FIGO staging classification, please refer to Appendix 7).
•4.A biopsy or cytology confirming the presence of high-grade serous epithelial ovarian carcinoma
•5.Preoperative imaging (CT and/or MRI), describing metastatic implants, as standard of care.
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1.Participant has a history of following diseases:
•a.Hyperthyroidism
•b.Autonomously functioning thyroid adenoma
•2.Participant has an allergy or hypersensitivity for one or more of the following components:
•a.Iodine (including potassium iodine)
•b.Indocyanine green
•3.Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol.
•4.Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial.
•5.Participation in an interventional Trial with an investigational medicinal product (IMP) or device during the surgery itself.
•6.Participant has a severe renal impairment (classified as eGFR<30 ml/min/1,73m2 according to CKD-EPI).
•7.Participant utilises sodium bisulfite-containing heparin preparations during the day before surgery. For Belgian registered drugs, this contains:
•a.Danaparoïde (Orgaran®)
•b.Other low-molecular weight heparins registered in Belgium do not contain sodium bisulfite and are not an exclusion criterion.
•8.Participants requires thyroid scintigraphy utilising radioactive iodine one week after surgery.
•9.A previous history of major intra-abdominal surgery with potentially major adhesions and/or distorted anatomy.
•10.Participants utilises one of the interacting drugs listed in the protocol

发起方

niversity Hospitals Leuven (UZ Leuven)