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Clinical Trials/DRKS00023777
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.

Registry
who.int
Start Date
March 5, 2021
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Klinikum der Universität München, Campus Großhadern

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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