Clinical trial of blood-brain barrier disruption by pulsed ultrasound
The blood-brain barrier (BBB) limits the delivery of systemically administered drugs to the brain. Methods to circumvent the BBB have been developed, but none are used in standard clinical practice. The lack of adoption of existing methods is due to procedural invasiveness, serious adverse effects,...
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| Published in | Science translational medicine Vol. 8; no. 343; p. 343re2 |
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| Main Authors | , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
15.06.2016
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| Subjects | |
| Online Access | Get more information |
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| Abstract | The blood-brain barrier (BBB) limits the delivery of systemically administered drugs to the brain. Methods to circumvent the BBB have been developed, but none are used in standard clinical practice. The lack of adoption of existing methods is due to procedural invasiveness, serious adverse effects, and the complications associated with performing such techniques coincident with repeated drug administration, which is customary in chemotherapeutic protocols. Pulsed ultrasound, a method for disrupting the BBB, was shown to effectively increase drug concentrations and to slow tumor growth in preclinical studies. We now report the interim results of an ultrasound dose-escalating phase 1/2a clinical trial using an implantable ultrasound device system, SonoCloud, before treatment with carboplatin in patients with recurrent glioblastoma (GBM). The BBB of each patient was disrupted monthly using pulsed ultrasound in combination with systemically injected microbubbles. Contrast-enhanced magnetic resonance imaging (MRI) indicated that the BBB was disrupted at acoustic pressure levels up to 1.1 megapascals without detectable adverse effects on radiologic (MRI) or clinical examination. Our preliminary findings indicate that repeated opening of the BBB using our pulsed ultrasound system, in combination with systemic microbubble injection, is safe and well tolerated in patients with recurrent GBM and has the potential to optimize chemotherapy delivery in the brain. |
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| AbstractList | The blood-brain barrier (BBB) limits the delivery of systemically administered drugs to the brain. Methods to circumvent the BBB have been developed, but none are used in standard clinical practice. The lack of adoption of existing methods is due to procedural invasiveness, serious adverse effects, and the complications associated with performing such techniques coincident with repeated drug administration, which is customary in chemotherapeutic protocols. Pulsed ultrasound, a method for disrupting the BBB, was shown to effectively increase drug concentrations and to slow tumor growth in preclinical studies. We now report the interim results of an ultrasound dose-escalating phase 1/2a clinical trial using an implantable ultrasound device system, SonoCloud, before treatment with carboplatin in patients with recurrent glioblastoma (GBM). The BBB of each patient was disrupted monthly using pulsed ultrasound in combination with systemically injected microbubbles. Contrast-enhanced magnetic resonance imaging (MRI) indicated that the BBB was disrupted at acoustic pressure levels up to 1.1 megapascals without detectable adverse effects on radiologic (MRI) or clinical examination. Our preliminary findings indicate that repeated opening of the BBB using our pulsed ultrasound system, in combination with systemic microbubble injection, is safe and well tolerated in patients with recurrent GBM and has the potential to optimize chemotherapy delivery in the brain. |
| Author | Carpentier, Alexandre Chapelon, Jean-Yves Canney, Michael Horodyckid, Catherine Idbaih, Ahmed Leclercq, Delphine Beccaria, Kevin Capelle, Laurent Vignot, Alexandre Lafon, Cyril Karachi, Carine Hoang-Xuan, Khê Sanson, Marc Cornu, Philippe Delattre, Jean-Yves Reina, Vincent |
| Author_xml | – sequence: 1 givenname: Alexandre surname: Carpentier fullname: Carpentier, Alexandre email: alexandre.carpentier@aphp.fr organization: Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires La Pitié-Salpêtrière, Service de Neurochirurgie, F-75013 Paris, France. Sorbonne Universités, UPMC Univ Paris 06, UMR S 1127, F-75013 Paris, France. alexandre.carpentier@aphp.fr – sequence: 2 givenname: Michael surname: Canney fullname: Canney, Michael organization: CarThera, Institut du Cerveau et de la Moelle épinière (ICM), Paris F-75013, France – sequence: 3 givenname: Alexandre surname: Vignot fullname: Vignot, Alexandre organization: CarThera, Institut du Cerveau et de la Moelle épinière (ICM), Paris F-75013, France – sequence: 4 givenname: Vincent surname: Reina fullname: Reina, Vincent organization: Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires La Pitié-Salpêtrière, Service de Neurochirurgie, F-75013 Paris, France. Sorbonne Universités, UPMC Univ Paris 06, UMR S 1127, F-75013 Paris, France – sequence: 5 givenname: Kevin surname: Beccaria fullname: Beccaria, Kevin organization: Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires La Pitié-Salpêtrière, Service de Neurochirurgie, F-75013 Paris, France – sequence: 6 givenname: Catherine surname: Horodyckid fullname: Horodyckid, Catherine organization: Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires La Pitié-Salpêtrière, Service de Neurochirurgie, F-75013 Paris, France – sequence: 7 givenname: Carine surname: Karachi fullname: Karachi, Carine organization: Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires La Pitié-Salpêtrière, Service de Neurochirurgie, F-75013 Paris, France. Sorbonne Universités, UPMC Univ Paris 06, UMR S 1127, F-75013 Paris, France – sequence: 8 givenname: Delphine surname: Leclercq fullname: Leclercq, Delphine organization: AP-HP, Hôpitaux Universitaires La Pitié-Salpêtrière-Charles Foix, Service de Neuroradiologie, F-75013 Paris, France – sequence: 9 givenname: Cyril surname: Lafon fullname: Lafon, Cyril organization: INSERM, U1032, LabTau, Lyon F-69003, France – sequence: 10 givenname: Jean-Yves surname: Chapelon fullname: Chapelon, Jean-Yves organization: INSERM, U1032, LabTau, Lyon F-69003, France – sequence: 11 givenname: Laurent surname: Capelle fullname: Capelle, Laurent organization: Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires La Pitié-Salpêtrière, Service de Neurochirurgie, F-75013 Paris, France – sequence: 12 givenname: Philippe surname: Cornu fullname: Cornu, Philippe organization: Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires La Pitié-Salpêtrière, Service de Neurochirurgie, F-75013 Paris, France. Sorbonne Universités, UPMC Univ Paris 06, UMR S 1127, F-75013 Paris, France – sequence: 13 givenname: Marc surname: Sanson fullname: Sanson, Marc organization: Sorbonne Universités, UPMC Univ Paris 06, UMR S 1127, F-75013 Paris, France. INSERM, U 1127, F-75013 Paris, France. CNRS, UMR 7225, F-75013, Paris, France. ICM, F-75013 Paris, France. AP-HP, Hôpitaux Universitaires La Pitié-Salpêtrière-Charles Foix, Service de Neurologie 2-Mazarin, F-75013 Paris, France – sequence: 14 givenname: Khê surname: Hoang-Xuan fullname: Hoang-Xuan, Khê organization: Sorbonne Universités, UPMC Univ Paris 06, UMR S 1127, F-75013 Paris, France. INSERM, U 1127, F-75013 Paris, France. CNRS, UMR 7225, F-75013, Paris, France. ICM, F-75013 Paris, France. AP-HP, Hôpitaux Universitaires La Pitié-Salpêtrière-Charles Foix, Service de Neurologie 2-Mazarin, F-75013 Paris, France – sequence: 15 givenname: Jean-Yves surname: Delattre fullname: Delattre, Jean-Yves organization: Sorbonne Universités, UPMC Univ Paris 06, UMR S 1127, F-75013 Paris, France. INSERM, U 1127, F-75013 Paris, France. CNRS, UMR 7225, F-75013, Paris, France. ICM, F-75013 Paris, France. AP-HP, Hôpitaux Universitaires La Pitié-Salpêtrière-Charles Foix, Service de Neurologie 2-Mazarin, F-75013 Paris, France – sequence: 16 givenname: Ahmed surname: Idbaih fullname: Idbaih, Ahmed organization: Sorbonne Universités, UPMC Univ Paris 06, UMR S 1127, F-75013 Paris, France. INSERM, U 1127, F-75013 Paris, France. CNRS, UMR 7225, F-75013, Paris, France. ICM, F-75013 Paris, France. AP-HP, Hôpitaux Universitaires La Pitié-Salpêtrière-Charles Foix, Service de Neurologie 2-Mazarin, F-75013 Paris, France |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/27306666$$D View this record in MEDLINE/PubMed |
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