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

Phase 1

Recruiting

• Conditions: Q87; Other specified congenital malformation syndromes affecting multiple systems

• Registration Number: DRKS00023777
• Lead Sponsor: Klinikum der Universität München, Campus Großhadern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical success (degree of devascularization) compared with conventional intervention using sonography and fluoroscopy.

Secondary Outcome Measures

Name	Time	Method
- Visualization of vascular malformations during minimally invasive MR-assisted percutaneous sclerotherapy in the context of study-controlled data collection. <br>- Feasibility of the above therapy.<br>- Morbidity and mortality of MR-assisted percutaneous sclerotherapy compared with conventional intervention using sonography and fluoroscopy.<br>- Cost-effectiveness of MR-guided percutaneous sclerotherapy compared with conventional intervention using sonography and X-ray fluoroscopy.<br>- Clinical outcome (subjective grading of symptom severity) compared to conventional intervention by sonography and radioscopy and evaluation of disease-related quality of life by questionnaires (SF-36v2/SF-10) pre- and postintervention after 3, 6 and 12 months.