IXSI: Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA during the radioembolisation pretreatment procedure

MC Utrecht0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

van der Velden S, Kunnen B, Koppert WJC, et al. A Dual-layer Detector for Simultaneous Fluoroscopic and Nuclear Imaging. Radiology. 2019;290(3):833-838. https://doi.org/10.1148/radiol.2018180796. 2. Dietze MMA, Kunnen B, van der Velden S, et al. Performance of a dual-layer scanner for hybrid SPECT/CBCT. Phys Med Biol. 2019;64(10):105020. http://dx.doi.org/10.1088/1361-6560/ab15f6. 3. Dietze MMA, Kunnen B, Brontsema F, et al. A Compact and Mobile Hybrid C-arm Scanner for Simultaneous Nuclear and Fluoroscopic Image Guidance. Submitted to Eur. Radiol. Aug 2020

•Participants will be recruited from patients, which are clinically selected to undergo a radioembolisation treatment at the UMC Utrecht. This will be adult men and women with liver tumour(s), that have no curative treatment options. The patient’s indication for hepatic radioembolisation will be discussed in a multidisciplinary tumour board.
•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•1.Participants must have given written informed consent and comply with the re-quirements of the study protocol.
•2.Must be aged 18 years or over.
•3.Must be selected to undergo a 99mTc-MAA procedure as part of their radioembolisa-tion treatment.
•4.Sufficiently fit to undergo an additional examination time of 30-90 minutes.
•5.Have a CT acquired less than 6 weeks before the pretreatment radioembolisation procedure.

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•1.Patients expected to require more than two injection positions for radioembolisa-tion treatment.
•2.Pregnancy or nursing.
•3.Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
•4.Patients who are declared incompetent.
•5.Previous enrollment in the present study
•6.Claustrophobia
•7.The last dose of prior chemotherapy has been received less than 4 weeks prior to the planned 99mTc-MAA pretreatment procedure.
•8.Radiation therapy within the last 4 weeks before the planned 99mTc-MAA pretreat-ment procedure
•9.Major surgery within the last 4 weeks prior to the planned 99mTc-MAA pretreatment procedure
•10.Any unresolved toxicity greater than Common Terminology Criteria for Adverse Events (CTCAE version 5, see appendix A) grade 2 from previous anti-cancer treatment
•11.Body weight over 250 kg (because of maximum table load)
•12.Patient length over 1.90 m (to fit IXSI geometry)
•13.Patient bust line over 135 cm (to fit IXSI geometry)

发起方

MC Utrecht