Trial reportProceedings of the National Academy of Sciences of the United States of America2021
Localized blood-brain barrier opening in infiltrating gliomas with MRI-guided acoustic emissions-controlled focused ultrasound.
Trial report in Proceedings of the National Academy of Sciences of the United States of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03322813 (A Study to Evaluate the Safety and Feasibility of Exablate Model 4000 Type-2 to Temporarily Mediate Blood-Brain Barrier Disruption), which is not on this map. Cited by 90 papers, 1 of them a synthesis that pooled 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.
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.
A Study to Evaluate the Safety and Feasibility of Exablate Model 4000 Type-2 to Temporarily Mediate Blood-Brain Barrier Disruption (BBBD) in Patients With Suspected Infiltrating Glioma in the Setting of Planned Surgical Interventions
Who cites it
90 citing papers in PubMed, 1 synthesis or guideline pooled it, 160 citations in OpenAlex.
- Focused ultrasound-mediated enhancement of blood-brain barrier permeability for brain tumor treatment: a systematic review of clinical trials.Journal of neuro-oncology · 2024Pooled it
- Microbubble-enhanced transcranial focused ultrasound with temozolomide for patients with high-grade glioma (BT008NA): a multicentre, open-label, phase 1/2 trial.The Lancet. Oncology · 2025Trial
- 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.Nature communications · 2024Trial
- Exploring the landscape of targetable alterations in patients with glioblastoma.Nature reviews. Clinical oncology · 2026Review
- Applications of transcranial focused ultrasound for primary brain tumors.Neuro-oncology advances · 2026Review
- Development of skull-implanted ultrasound for blood-brain barrier opening and drug delivery in neuro-oncology.Neuro-oncology advances · 2026Review
- Tuning endothelial barrier permeability with ultrasound: a pulse-length-dependent interplay between bubble dynamics and cellular bioeffects.Ultrasonics sonochemistry · 2026Article
- Focused ultrasound in pediatric neuro-oncology: Current applications and future directions.Neuro-oncology advances · 2026Review
- Tunable Technologies for the Glioma Tumor Microenvironment: A Comprehensive Review on Bench-to-Bedside Neurosurgical Advances.Brain sciences · 2026Review
- Focused ultrasound expands intra-CSF AAV delivery to deep brain regions in rats and non-human primates.Molecular therapy : the journal of the American Society of Gene Therapy · 2026Article
- Intranasal vs. Device-Assisted Drug Delivery: Advantages and Limitations for the Delivery of Biopharmaceuticals to the CNS.Pharmaceutics · 2026Review
- Locoregional Delivery of miRNAs for Glioblastoma Treatment: A Systematic Review of Advances in Delivery Systems.Pharmaceutics · 2026Review
- Dominant Temporo-Basal Glioblastoma with Rapid Progressive Aphasia: Venous-Anchored Maximal Safe Resection and Quantified Language Recovery.Diagnostics (Basel, Switzerland) · 2026Article
- Data-Driven Feedback Identifies Focused Ultrasound Exposure Regimens for Improved Nanotheranostic Targeting of the Brain.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Bridging the blood-brain barrier: strategies to improve delivery of biologics to tumors in the brain.Fluids and barriers of the CNS · 2026Review
- Review
- Outpatient Surgery in Neuro-Oncology-Advancing Patient Access and Care.Current oncology (Toronto, Ont.) · 2026Review
- How do tumor-associated neutrophils regulate the microenvironmental landscape of brain tumors: Delivery of nano-particles through BBB.PLoS computational biology · 2026Article
- Precision Drug Delivery Strategies for Treatment-Resistant Depression: Opportunities and Challenges of FUS-BBBO and Spatial Molecular Profiling.Drug design, development and therapy · 2026Review
- Hysteresis in cavitation emissions during a ramped-then-deramped amplitude sonication: A theoretical and experimental investigation.Nonlinear dynamics · 2026Article
30 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
Abstract
Pharmacological treatment of gliomas and other brain-infiltrating tumors remains challenging due to limited delivery of most therapeutics across the blood-brain barrier (BBB). Transcranial MRI-guided focused ultrasound (FUS), an emerging technology for noninvasive brain treatments, enables transient opening of the BBB through acoustic activation of circulating microbubbles. Here, we evaluate the safety and utility of transcranial microbubble-enhanced FUS (MB-FUS) for spatially targeted BBB opening in patients with infiltrating gliomas. In this Phase 0 clinical trial (NCT03322813), we conducted comparative and quantitative analyses of FUS exposures (sonications) and their effects on gliomas using MRI, histopathology, microbubble acoustic emissions (harmonic dose [HD]), and fluorescence-guided surgery metrics. Contrast-enhanced MRI and histopathology indicated safe and reproducible BBB opening in all patients. These observations occurred using a power cycling closed feedback loop controller, with the power varying by nearly an order of magnitude on average. This range underscores the need for monitoring and titrating the exposure on a patient-by-patient basis. We found a positive correlation between microbubble acoustic emissions (HD) and MR-evident BBB opening (
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What OpenQuestion holds
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.