DRKS00023777
Recruiting
Phase 1
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 sites30 target enrollmentMarch 5, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Q87
- Sponsor
- Klinikum der Universität München, Campus Großhadern
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Not specified
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