Evidence map›Paper›PMID 37142373›Full record

ArticleThe Lancet. Oncology2023

Repeated blood-brain barrier opening with an implantable ultrasound device for delivery of albumin-bound paclitaxel in patients with recurrent glioblastoma: a phase 1 trial.

Adam M Sonabend, Andrew Gould, Christina Amidei, Rachel Ward, Karyn A Schmidt, Daniel Y Zhang, Cristal Gomez, John F Bebawy, Benjamin P Liu, Guillaume Bouchoux and 12 more

3 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in The Lancet. Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 140 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
140citing papers in PubMed, 3 pooled it
22.8field-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.

NCT04528680 phase1 / phase2active not recruitingnot on this map

Phase 1 / 2 Trial of Blood-brain Barrier Opening With an Implantable Ultrasound Device SonoCloud-9 and Treatment With Albumin-bound Paclitaxel and Carboplatin in Patients With Recurrent Glioblastoma

TypeinterventionalSponsorNorthwestern UniversityRan2020 to 2026Enrolled57ConditionsGlioblastoma, Gliosarcoma, GBM, Glioblastoma MultiformeArmsSonication for opening of blood-brain barrier, Chemotherapy, albumin-bound paclitaxel, Chemotherapy, carboplatin
NCT05902169 phase3recruitingnot on this mapstarted 2024, after this paper: background citation

A Randomized, Open-label, Multicentric, Two-arm Pivotal Trial of SonoCloud-9 Combined With Carboplatin (CBDCA) vs Standard of Care Lomustine (CCNU) or Temozolomide (TMZ) in Patients Undergoing Planned Resection for First Recurrence Glioblastoma.

TypeinterventionalSponsorCarTheraRan2024 to 2028Enrolled560ConditionsGlioblastoma, Recurrent Glioblastoma, GBMArmsSonoCloud-9 (SC9), Carboplatin, Lomustine, Temozolomide
NCT06330337 phase3recruitingnot on this mapstarted 2024, after this paper: background citation

Specific Model Electroacupuncture Stimulation Promotes Paclitaxel Delivery Across the BBB for Postoperative Glioma Patients: A Randomized Controlled Study

TypeinterventionalSponsorThe Third Affiliated hospital of Zhejiang Chinese Medical UniversityRan2024 to 2027Enrolled58ConditionsGliomaArmsTemozolomide(TMZ) injection or oral administration, Albumin-Bound Paclitaxel(ABX) intravenous drip, Specific mode electroacupuncture stimulation(SMES) intervention
3 · Its place in the literature

Who cites it

140 citing papers in PubMed, 3 syntheses or guidelines pooled it, 203 citations in OpenAlex.

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  5. 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
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  18. Construction of a survival prediction model and analysis of influencing factors for brain metastasis in non-small cell lung cancer based on multi‑parameter clinical data.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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80 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 6 institutions in 3 countries.

Adam M SonabendDepartment of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Northwestern Medicine Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. Electronic address: adam.sonabend@northwestern.edu.
Andrew GouldDepartment of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Northwestern Medicine Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Christina AmideiDepartment of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Northwestern Medicine Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Rachel WardDepartment of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Northwestern Medicine Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Karyn A SchmidtDepartment of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Northwestern Medicine Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Daniel Y ZhangDepartment of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Northwestern Medicine Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Rush Medical College, Chicago, IL, USA.
Cristal GomezDepartment of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Northwestern Medicine Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
John F BebawyDepartment of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Anesthesiology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Benjamin P LiuNorthwestern Medicine Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Radiology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Radiation Oncology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Guillaume BouchouxCarthera, Lyon, France.
Carole DesseauxCarthera, Lyon, France.
Irene B HelenowskiDepartment of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Rimas V LukasNorthwestern Medicine Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Karan DixitNorthwestern Medicine Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Priya KumthekarNorthwestern Medicine Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Víctor A ArrietaDepartment of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Northwestern Medicine Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; PECEM, Facultad de Medicina, Universidad Nacional Autónoma de México, Mexico City, Mexico.
Maciej S LesniakDepartment of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Northwestern Medicine Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Alexandre CarpentierService de Neurochirurgie, Hôpital Pitie Salpetriere, AP-HP Sorbonne Université, Paris, France; GRC no 23, Interface Neuro Machine Team, Sorbonne Université, Paris, France.
Hui ZhangNorthwestern Medicine Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Miguel MuzzioIITResearch Institute, Chicago, IL, USA.
Michael CanneyCarthera, Lyon, France.
Roger StuppDepartment of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Northwestern Medicine Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Division of Hematology/Oncology, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Northwestern University · USNeurological Surgery · USNorthwestern Medicine · USIIT Research Institute · USNeurON : Interface Neuro-machineUniversidad Nacional Autónoma de México · MX

Funding

STINGing GBM: A First-in- Man Clinical Trial in Surgical Resectable Recurrent GBMP50CA221747 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI Atique U. Ahmed · 2018 to 2026
$21.4M
Blood-brain barrier disruption with implantable ultrasound to enhance paclitaxel delivery: A Phase 1-2 clinical trial in recurrent glioblastomaR01CA245969 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI Adam M Sonabend, Roger Stupp · 2020 to 2026
$2.8M
NCI NIH HHS P50 CA221747NCI NIH HHS R01 CA245969
6 · The paper itself

Abstract

backgroundLow-intensity pulsed ultrasound with concomitant administration of intravenous microbubbles (LIPU-MB) can be used to open the blood-brain barrier. We aimed to assess the safety and pharmacokinetics of LIPU-MB to enhance the delivery of albumin-bound paclitaxel to the peritumoural brain of patients with recurrent glioblastoma.

methodsWe conducted a dose-escalation phase 1 clinical trial in adults (aged ≥18 years) with recurrent glioblastoma, a tumour diameter of 70 mm or smaller, and a Karnofsky performance status of at least 70. A nine-emitter ultrasound device was implanted into a skull window after tumour resection. LIPU-MB with intravenous albumin-bound paclitaxel infusion was done every 3 weeks for up to six cycles. Six dose levels of albumin-bound paclitaxel (40 mg/m

findings17 patients (nine men and eight women) were enrolled between Oct 29, 2020, and Feb 21, 2022. As of data cutoff on Sept 6, 2022, median follow-up was 11·89 months (IQR 11·12-12·78). One patient was treated per dose level of albumin-bound paclitaxel for levels 1 to 5 (40-215 mg/m

interpretationLIPU-MB using a skull-implantable ultrasound device transiently opens the blood-brain barrier allowing for safe, repeated penetration of cytotoxic drugs into the brain. This study has prompted a subsequent phase 2 study combining LIPU-MB with albumin-bound paclitaxel plus carboplatin (NCT04528680), which is ongoing.

fundingNational Institutes of Health and National Cancer Institute, Moceri Family Foundation, and the Panattoni family.

Indexed as

Brain DiseasesGlioblastomaAdolescentAdultAlbumin-Bound PaclitaxelAntineoplastic Combined Chemotherapy ProtocolsBlood-Brain BarrierCarboplatinFemaleHumansMalePaclitaxelAlbumin-Bound PaclitaxelCarboplatinPaclitaxel

Identifiers

PMID37142373
PMCPMC10256454
OpenAlexW4367673693

What OpenQuestion holds

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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.