Evidence map›Paper›PMID 33547073›Full record

Trial reportScience advances2021

Neuronavigation-guided focused ultrasound for transcranial blood-brain barrier opening and immunostimulation in brain tumors.

Ko-Ting Chen, Wen-Yen Chai, Ya-Jui Lin, Chia-Jung Lin, Pin-Yuan Chen, Hong-Chieh Tsai, Chiung-Yin Huang, John S Kuo, Hao-Li Liu, Kuo-Chen Wei

3 registry-linked trialsOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in Science advances, 2021. 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 104 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
104citing papers in PubMed, 3 pooled it
10.4field-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.

NCT04988750 nacompletednot on this map

An Open Label, Prospective, Pilot Study to Evaluate the Safety and Preliminary Efficacy of the Combination of Focused Ultrasound With Re-irradiation for the Treatment Patients With Recurrent Glioblastoma Multiforme Using NaviFUS System

TypeinterventionalSponsorNaviFUS CorporationRan2021 to 2025Enrolled7ConditionsRecurrent Glioblastoma, High-Grade Glioma (WHO III-IV), Brain Tumor Recurrent, Brain Tumor AdultArmsNaviFUS System
NCT06329570 phase1 / phase2recruitingnot on this mapstarted 2024, after this paper: background citation

A Prospective, Open-Label, Single-Arm Pilot Study to Evaluate the Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)

TypeinterventionalSponsorNaviFUS CorporationRan2024 to 2028Enrolled10ConditionsGlioblastoma Multiforme, Glioblastoma, Glioma, Brain TumorArmsNaviFUS System, Lumason, Bevacizumab
NCT06496971 phase3recruitingnot on this mapstarted 2024, after this paper: background citation

A Prospective, Randomized, Standard of Care Controlled, Parallel, Open-Label, Multicenter Pivotal Study to Evaluate the Efficacy and Safety of Avastin® in Combination With NaviFUS System Compared With Avastin® Alone for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)

TypeinterventionalSponsorNaviFUS CorporationRan2024 to 2027Enrolled32ConditionsGlioblastoma Multiforme, Glioblastoma, Glioblastoma Multiforme, Adult, GliomaArmsBevacizumab, Microbubble, Low-Intensity Focused Ultrasound
3 · Its place in the literature

Who cites it

104 citing papers in PubMed, 3 syntheses or guidelines pooled it, 190 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Localized blood-brain barrier opening in infiltrating gliomas with MRI-guided acoustic emissions-controlled focused ultrasound.Proceedings of the National Academy of Sciences of the United States of America · 2021
    Trial
  6. Article
  7. Review
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  9. Focused ultrasound for brain metastases.Neuro-oncology advances · 2026
    Review
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  11. Review
  12. Article
  13. Review
  14. Article
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  16. Article
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  20. Article

44 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

10 authors at 5 institutions in 2 countries.

Ko-Ting ChenDepartment of Neurosurgery, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan.ORCID 0000-0002-6795-5974
Wen-Yen ChaiDepartment of Diagnostic Radiology and Intervention, Chang Gung Memorial Hospital at LinKou, Taoyuan, Taiwan.ORCID 0000-0001-9169-9643
Ya-Jui LinDepartment of Neurosurgery, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan.ORCID 0000-0002-4339-0147
Chia-Jung LinDepartment of Electrical Engineering, National Taiwan University, Taipei, Taiwan.ORCID 0000-0001-6015-0236
Pin-Yuan ChenDepartment of Neurosurgery, Chang Gung Memorial Hospital at Keelung, Keelung, Taiwan.ORCID 0000-0003-3324-0695
Hong-Chieh TsaiDepartment of Neurosurgery, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan.ORCID 0000-0003-3994-1601
Chiung-Yin HuangDepartment of Neurosurgery, New Taipei Municipal TuCheng Hospital, Chang Gung Medical Foundation, New Taipei, Taiwan.ORCID 0000-0001-6954-9737
John S KuoDepartment of Neurosurgery and Mulva Clinic for the Neurosciences, Dell Medical School, The University of Texas at Austin, Austin, TX 78712, USA.ORCID 0000-0001-6809-4806
Hao-Li LiuDepartment of Electrical Engineering, National Taiwan University, Taipei, Taiwan. kuochenwei@cgmh.org.tw hlliu@ntu.edu.tw.ORCID 0000-0003-1541-1227
Kuo-Chen WeiDepartment of Neurosurgery, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan. kuochenwei@cgmh.org.tw hlliu@ntu.edu.tw.ORCID 0000-0003-3505-2196
Chang Gung University · TWChang Gung Memorial Hospital · TWNational Taiwan University · TWLinkou Chang Gung Memorial Hospital · TWThe University of Texas at Austin · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Focused ultrasound (FUS) in the presence of microbubbles can transiently open the blood-brain barrier (BBB) to increase therapeutic agent penetration at the targeted brain site to benefit recurrent glioblastoma (rGBM) treatment. This study is a dose-escalating pilot trial using a device combining neuronavigation and a manually operated frameless FUS system to treat rGBM patients. The safety and feasibility were established, while a dose-dependent BBB-opening effect was observed, which reverted to baseline within 24 hours after treatment. No immunological response was observed clinically under the applied FUS level in humans; however, selecting a higher level in animals resulted in prolonged immunostimulation, as confirmed preclinically by the recruitment of lymphocytes into the tumor microenvironment (TME) in a rat glioma model. Our findings provide preliminary evidence of FUS-induced immune modulation as an additional therapeutic benefit by converting the immunosuppressive TME into an immunostimulatory TME via a higher but safe FUS dosage.

Indexed as

Brain NeoplasmsGlioblastomaAnimalsBlood-Brain BarrierBrainDrug Delivery SystemsHumansImmunizationMagnetic Resonance ImagingMicrobubblesNeuronavigationRatsTumor Microenvironment

Identifiers

PMID33547073
PMCPMC7864566
OpenAlexW3126434346

What OpenQuestion holds

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LicenceCC BY-NC
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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.