Repeated blood–brain barrier opening with a nine-emitter implantable ultrasound device in combination with carboplatin in recurrent glioblastoma: a phase I/II clinical trial

Alexandre Carpentier (), Roger Stupp, Adam M. Sonabend, Henry Dufour, Olivier Chinot, Bertrand Mathon, François Ducray, Jacques Guyotat, Nathalie Baize, Philippe Menei, John Groot, Jeffrey S. Weinberg, Benjamin P. Liu, Eric Guemas, Carole Desseaux, Charlotte Schmitt, Guillaume Bouchoux, Michael Canney and Ahmed Idbaih
Additional contact information
Alexandre Carpentier: Sorbonne Université, AP-HP, Hôpitaux Universitaires La Pitié Salpêtrière - Charles Foix, Service de Neurochirurgie
Roger Stupp: Northwestern University
Adam M. Sonabend: Northwestern University
Henry Dufour: Aix-Marseille Univ, APHM, CNRS, INP, Inst Neurophysiopathol, CHU Timone, Service de Neuro-Oncologie
Olivier Chinot: Aix-Marseille Univ, APHM, CNRS, INP, Inst Neurophysiopathol, CHU Timone, Service de Neuro-Oncologie
Bertrand Mathon: Sorbonne Université, AP-HP, Hôpitaux Universitaires La Pitié Salpêtrière - Charles Foix, Service de Neurochirurgie
François Ducray: Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Service de Neuro-Oncologie, Hospices Civils de Lyon, Cancer Research Center of Lyon, INSERM U1052, CNRS UMR 5286, Cancer Cell Plasticity Department
Jacques Guyotat: Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Service de Neuro-Oncologie, Hospices Civils de Lyon, Cancer Research Center of Lyon, INSERM U1052, CNRS UMR 5286, Cancer Cell Plasticity Department
Nathalie Baize: CHU Angers
Philippe Menei: CHU Angers
John Groot: University of California
Jeffrey S. Weinberg: The University of Texas MD Anderson Cancer Center
Benjamin P. Liu: Northwestern University
Eric Guemas: Biossec
Carole Desseaux: Carthera
Charlotte Schmitt: Carthera
Guillaume Bouchoux: Carthera
Michael Canney: Carthera
Ahmed Idbaih: Sorbonne Université, Inserm, CNRS, UMR S 1127, Institut du Cerveau, ICM, AP-HP, Hôpitaux Universitaires La Pitié Salpêtrière - Charles Foix, Service de Neuro-Oncologie

Nature Communications, 2024, vol. 15, issue 1, 1-12

Abstract: Abstract Here, the results of a phase 1/2 single-arm trial (NCT03744026) assessing the safety and efficacy of blood-brain barrier (BBB) disruption with an implantable ultrasound system in recurrent glioblastoma patients receiving carboplatin are reported. A nine-emitter ultrasound implant was placed at the end of tumor resection replacing the bone flap. After surgery, activation to disrupt the BBB was performed every four weeks either before or after carboplatin infusion. The primary objective of the Phase 1 was to evaluate the safety of escalating numbers of ultrasound emitters using a standard 3 + 3 dose escalation. The primary objective of the Phase 2 was to evaluate the efficacy of BBB opening using magnetic resonance imaging (MRI). The secondary objectives included safety and clinical efficacy. Thirty-three patients received a total of 90 monthly sonications with carboplatin administration and up to nine emitters activated without observed DLT. Grade 3 procedure-related adverse events consisted of pre syncope (n = 3), fatigue (n = 1), wound infection (n = 2), and pain at time of device connection (n = 7). BBB opening endpoint was met with 90% of emitters showing BBB disruption on MRI after sonication. In the 12 patients who received carboplatin just prior to sonication, the progression-free survival was 3.1 months, the 1-year overall survival rate was 58% and median overall survival was 14.0 months from surgery.

Date: 2024
References: View complete reference list from CitEc
Citations: View citations in EconPapers (1)

Downloads: (external link)
https://www.nature.com/articles/s41467-024-45818-7 Abstract (text/html)

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:nat:natcom:v:15:y:2024:i:1:d:10.1038_s41467-024-45818-7

Ordering information: This journal article can be ordered from
https://www.nature.com/ncomms/

DOI: 10.1038/s41467-024-45818-7

Access Statistics for this article

Nature Communications is currently edited by Nathalie Le Bot, Enda Bergin and Fiona Gillespie

More articles in Nature Communications from Nature
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().