SONOBIRD

- A randomized, open-label, multicenter, two-arm study of SonoCloud-9 combined with carboplatin versus standard lomustine (CCNU) or temozolomide (TMZ) therapy in patients with operable first recurrence of glioblastoma - Implantable device that is used as a bone flap replacement after resection of the recurrence. Using specific ultrasound frequencies and a substance (microbubbles), the blood-brain barrier can be temporarily opened so that large-molecule chemotherapeutic agents, such as carboplatin, can also penetrate the tissue.

{ "short_title": "SONOBIRD", "data_mode": "900", "data_mode_number": "000002425", "official_title": "SonoCloud for Bbb opening In gbm Recurrent Disease", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "kurativ", "therapieintervention_value": "adjuvant", "therapielinie_value": "second", "ctgov_number": null, "eudract_number": null, "general_contact_email": "andrea.sorokin@ukkd.de", "general_contact_phone": "0351-4584828", "hauptpruefer_dd_name": null, "description_laie_de": "- Eine randomisierte, offene, multizentrische, zweiarmige Studie mit SonoCloud-9 kombiniert mit Carboplatin versus Standard Lomustin (CCNU) oder Temozolomid (TMZ) Therapie bei Patienten mit operablem ersten Rezidiv eines Glioblastoms\r\n- Implantierbares Device, das nach Resektion des Rezidivs als Knochendeckelersatz eingesetzt wird. Mittels spezifischer Ultraschallfrequenzen und einer Substanz (microbubbles) l\u00e4sst sich die Blut-Hirn-Schranke vor\u00fcbergehend \u00f6ffnen, sodass auch gro\u00dfmolekulare Chemotherpeutika in das Gewebe eindringen k\u00f6nnen, wie z.B. Carboplatin.", "description_laie_en": "- A randomized, open-label, multicenter, two-arm study of SonoCloud-9 combined with carboplatin versus standard lomustine (CCNU) or temozolomide (TMZ) therapy in patients with operable first recurrence of glioblastoma\r\n- Implantable device that is used as a bone flap replacement after resection of the recurrence. Using specific ultrasound frequencies and a substance (microbubbles), the blood-brain barrier can be temporarily opened so that large-molecule chemotherapeutic agents, such as carboplatin, can also penetrate the tissue.", "description_expert_de": "- Eine randomisierte, offene, multizentrische, zweiarmige Studie mit SonoCloud-9 kombiniert mit Carboplatin versus Standard Lomustin (CCNU) oder Temozolomid (TMZ) Therapie bei Patienten mit operablem ersten Rezidiv eines Glioblastoms\r\n- Implantierbares Device, das nach Resektion des Rezidivs als Knochendeckelersatz eingesetzt wird. Mittels spezifischer Ultraschallfrequenzen und einer Substanz (microbubbles) l\u00e4sst sich die Blut-Hirn-Schranke vor\u00fcbergehend \u00f6ffnen, sodass auch gro\u00dfmolekulare Chemotherpeutika in das Gewebe eindringen k\u00f6nnen, wie z.B. Carboplatin.", "description_expert_en": "- A randomized, open-label, multicenter, two-arm study of SonoCloud-9 combined with carboplatin versus standard lomustine (CCNU) or temozolomide (TMZ) therapy in patients with operable first recurrence of glioblastoma\r\n- Implantable device that is used as a bone flap replacement after resection of the recurrence. Using specific ultrasound frequencies and a substance (microbubbles), the blood-brain barrier can be temporarily opened so that large-molecule chemotherapeutic agents, such as carboplatin, can also penetrate the tissue.", "rechtsgrundlage_value": "MPG", "phase_amg_value": null, "main_cat_id": 8, "sub_cat_id": 42 }