Evidence map›Paper›PMID 38396134›Full record

Trial reportNature communications2024

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 and 9 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in Nature communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03744026 (A Study to Evaluate the Safety and the Efficacy of Transient Opening of the Blood-brain Barrier), which is not on this map. Cited by 77 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
77citing papers in PubMed, 4 pooled it
16.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03744026 phase1 / phase2completednot on this map

A Study to Evaluate the Safety and the Efficacy of Transient Opening of the Blood-brain Barrier (BBB) by Low Intensity Pulsed Ultrasound With the SonoCloud-9 Implantable Device in Recurrent Glioblastoma Patients Eligible for Surgery and for Carboplatin Chemotherapy

TypeinterventionalSponsorCarTheraRan2019 to 2022Enrolled38ConditionsGlioblastoma, AdultArmsSonoCloud-9, Carboplatin
3 · Its place in the literature

Who cites it

77 citing papers in PubMed, 4 syntheses or guidelines pooled it, 90 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Pharmacokinetic Analysis of Carboplatin and Fluorescein Brain Retention following Ultrasound-Based Blood-Brain Barrier Opening.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  7. Article
  8. Article
  9. Next-generation therapeutics for glioblastoma: Challenges and future directions.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Review
  10. Review
  11. Brain metastasis: Opportunities for novel therapies.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Review
  12. Immunotherapy for Glioma: A compartmental framework for resistance and rational combination design.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. Review

17 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 7 institutions in 2 countries.

Alexandre CarpentierSorbonne Université, AP-HP, Hôpitaux Universitaires La Pitié Salpêtrière - Charles Foix, Service de Neurochirurgie, Paris, France. alexandre.carpentier@aphp.fr.ORCID 0000-0001-7312-6358
Roger StuppDepartment of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.ORCID 0000-0002-5483-3118
Adam M SonabendDepartment of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.ORCID 0000-0002-8347-1945
Henry DufourAix-Marseille Univ, APHM, CNRS, INP, Inst Neurophysiopathol, CHU Timone, Service de Neuro-Oncologie, Marseille, France.
Olivier ChinotAix-Marseille Univ, APHM, CNRS, INP, Inst Neurophysiopathol, CHU Timone, Service de Neuro-Oncologie, Marseille, France.ORCID 0000-0001-6317-9691
Bertrand MathonSorbonne Université, AP-HP, Hôpitaux Universitaires La Pitié Salpêtrière - Charles Foix, Service de Neurochirurgie, Paris, France.ORCID 0000-0002-9182-5846
François DucrayHospices 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, Lyon, France.
Jacques GuyotatHospices 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, Lyon, France.
Nathalie BaizeCHU Angers, Angers, France.
Philippe MeneiCHU Angers, Angers, France.
John de GrootDepartments of Neurology and Neurosurgery, University of California, San Francisco, CA, USA.
Jeffrey S WeinbergDepartment of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0001-5587-6673
Benjamin P LiuDepartments of Radiology and Radiation Oncology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.ORCID 0000-0003-0122-3866
Eric GuemasBiossec, Paris, France.
Carole DesseauxCarthera, Lyon, France.
Charlotte SchmittCarthera, Lyon, France.
Guillaume BouchouxCarthera, Lyon, France.
Michael CanneyCarthera, Lyon, France.
Ahmed IdbaihSorbonne Université, Inserm, CNRS, UMR S 1127, Institut du Cerveau, ICM, AP-HP, Hôpitaux Universitaires La Pitié Salpêtrière - Charles Foix, Service de Neuro-Oncologie, Paris, France.
Centre National de la Recherche Scientifique · FRNorthwestern University · USCentre Hospitalier Universitaire d'Angers · FRSorbonne Université · FRUniversité Claude Bernard Lyon 1 · FRThe University of Texas MD Anderson Cancer Center · USUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Blood-Brain BarrierGlioblastomaAntineoplastic Combined Chemotherapy ProtocolsBiological TransportCarboplatinHumansUltrasonographyCarboplatin

Identifiers

PMID38396134
PMCPMC10891097
OpenAlexW4392107637

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.