Schmidt, Vanessa F. and Masthoff, Max and Vielsmeier, Veronika and Seebauer, Caroline T. and Cangir, Ozlem and Meyer, Lutz and Muekke, Antje and Lang, Werner and Schmid, Axel and Sporns, Peter B. and Brill, Richard and Wohlgemuth, Walter A. and da Silva, Natascha Platz Batista and Seidensticker, Max and Schinner, Regina and Kueppers, Julia and Haeberle, Beate and Haubner, Frank and Ricke, Jens and Zenker, Martin and Kimm, Melanie A. and Wildgruber, Moritz (2023) Clinical Outcome and Quality of Life of Multimodal Treatment of Extracranial Arteriovenous Malformations: The APOLLON Study Protocol. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 46 (1). pp. 142-151. ISSN 0174-1551, 1432-086X
Full text not available from this repository. (Request a copy)Abstract
Purpose Arteriovenous malformations (AVMs) as rare diseases are diagnostically and therapeutically challenging. Due to the limited evidence regarding treatment outcome, prospective data are needed on how different treatment regimens affect outcome. The aims of this prospective trial are to determine effectiveness, safety, and clinical outcome of multimodal treatment in patients with extracranial AVMs. Materials and Methods After clinical and magnetic resonance imaging (MRI)-based diagnosis and informed consent, 146 patients (> 4 years and < 70 years) undergoing multimodal therapy in tertiary care vascular anomalies centers will be included in this prospective observational trial. Treatment options include conservative management, medical therapy, minimally invasive image-guided procedures (embolization, sclerotherapy) and surgery as well as combinations of the latter. The primary outcome is the patient-reported QoL 6 months after completion of treatment using the short form-36 health survey version 2 (SF-36v2) and the corresponding short form-10 health survey (SF-10) for children. In addition, clinical presentation (physician-reported signs), MRI imaging (radiological assessment of devascularization), recurrence rate, and therapeutic safety will be analyzed. Further follow-up will be performed after 12, 24, and 36 months. Moreover, liquid biopsies are being obtained from peripheral blood at multiple time points to investigate potential biomarkers for therapy response and disease progression. Discussion The APOLLON trial is a prospective, multicenter, observational open-label trial with unequal study groups to generate prospective evidence for multimodal treatment of AVMs. A multicenter design with the potential to assess larger populations will provide an increased understanding of multimodal therapy outcome in this orphan disease.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | CIRCULATING ENDOTHELIAL-CELLS; VENOUS MALFORMATIONS; VASCULAR ANOMALIES; CLASSIFICATION; SCLEROTHERAPY; EMBOLIZATION; APOLLON trial; AVM; Multimodal therapy; Vascular malformations; QoL |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Hals-Nasen-Ohren-Heilkunde Medicine > Lehrstuhl für Röntgendiagnostik |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 06 Mar 2024 11:20 |
| Last Modified: | 06 Mar 2024 11:20 |
| URI: | https://pred.uni-regensburg.de/id/eprint/58013 |
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