Evaluation of feasibility and technical success of MR-assisted percutaneous sclerotherapy of slow-flow vascular malformations avoiding ionizing radiation. - MRI-GUY-study

Klinikum der Universität München, Campus Großhadern0 个研究点目标入组 30 人开始时间: 2021年3月5日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Clinical indication for percutaneous sclerotherapy of slow-flow vascular malformation (venous/lymphatic/combined malformation). The indication for intervention in this case must be independent of the presented study.
•- The localization of the vascular malformation is not or not sufficiently accessible by conventional imaging (sonography and X-ray fluoroscopy).
•- Previous therapy (surgery, embolization, sclerotherapy) without improvement of symptoms.
•- Platelets > 50,000/mm3 (50 GPt/l)
•- INR/PTT <1.5 times upper normal value (patients taking anticoagulants may be included if no underlying coagulation abnormality has been previously identified).
•- Signed informed consent form
•- Age: children and adults >4 years

•- Lack of informed consent and/or lack of capacity to consent to the study.
•- Contraindications to MRI examination, especially implants not suitable for MR, tattoos or piercings, limiting claustrophobia.
•- Contraindications to contrast agents (only in the case of MR contrast agent use):
•o Known allergy to MR contrast media.
•o Higher grade renal insufficiency (GFR <30 ml/min).
•- Contraindications to image-guided interstitial intervention.
•o Platelets < 50,000/mm3 (50 GPt/l)
•o INR/PTT> 1.5 -fold upper normal value
•o Presence of an abnormality of blood coagulation.
•- Patients with high-flow vascular malformations or other vascular abnormalities (vascular tumors).
•- Concomitant consumptive disease or ECOG > 1.
•- Contraindications for invasive treatments

发起方

Klinikum der Universität München, Campus Großhadern