ArticleAnnals of translational medicine2020
Neuronavigation-guided focused ultrasound (NaviFUS) for transcranial blood-brain barrier opening in recurrent glioblastoma patients: clinical trial protocol.
Article in Annals of translational medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 54 papers, 3 of them syntheses 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 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)
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)
Who cites it
54 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Focused ultrasound-induced blood-brain barrier modulation for drug delivery in recurrent glioblastoma: A systematic review.The Indian journal of medical research · 2026Pooled it
- 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
- Towards standardization of the parameters for opening the blood-brain barrier with focused ultrasound to treat glioblastoma multiforme: A systematic review of the devices, animal models, and therapeutic compounds used in rodent tumor models.Frontiers in oncology · 2022Pooled it
- A new in silico model to precisely design focused ultrasound brain therapies.Medical physics · 2026Article
- Glioblastoma: epidemiology, molecular pathogenesis, diagnosis, management, and therapeutic resistance.Molecular biomedicine · 2026Review
- Safety and neuromodulation effect of transcranial focused ultrasound for motor recovery in patients with subacute stroke.Journal of neuroengineering and rehabilitation · 2026Article
- Recent developments in peptide vaccines against Glioblastoma, a review and update.Molecular brain · 2025Review
- Oxygen Sensitive Drug Release Using Hemoglobin Microbubbles: A New Approach to Targeting Hypoxia in Ultrasound-Mediated Drug Delivery.International journal of pharmaceutics · 2025Article
- Ultrasound guided blood brain barrier opening using a diagnostic probe in a whole brain model.Scientific reports · 2025Article
- Identifying new therapeutics for focused ultrasound-enhanced drug delivery in the management of glioblastoma.Frontiers in oncology · 2025Review
- Acquired resistance to molecularly targeted therapies for cancer.Cancer drug resistance (Alhambra, Calif.) · 2025Review
- Effect of Microbubble Size, Composition, and Multiple Sonication Points on Sterile Inflammatory Response in Focused Ultrasound-Mediated Blood-Brain Barrier Opening.ACS biomaterials science & engineering · 2024Article
- Consensus review on strategies to improve delivery across the blood-brain barrier including focused ultrasound.Neuro-oncology · 2024Review
- Microbubble-Enhanced Focused Ultrasound for Infiltrating Gliomas.Biomedicines · 2024Review
- Overcoming Resistance to Temozolomide in Glioblastoma: A Scoping Review of Preclinical and Clinical Data.Life (Basel, Switzerland) · 2024Article
- Effect of Microbubble Size, Composition and Multiple Sonication Points on Sterile Inflammatory Response in Focused Ultrasound-Mediated Blood-Brain Barrier Opening.bioRxiv : the preprint server for biology · 2024Article
- Protocol to assess extravasation of fluorescent molecules in mice after ultrasound-mediated blood-brain barrier opening.STAR protocols · 2024Article
- Targeting diffuse midline gliomas: The promise of focused ultrasound-mediated blood-brain barrier opening.Journal of controlled release : official journal of the Controlled Release Society · 2024Review
- Therapeutic ultrasound: an innovative approach for targeting neurological disorders affecting the basal ganglia.Frontiers in neuroanatomy · 2024Review
- Therapeutic ultrasound transducer technology and monitoring techniques: a review with clinical examples.International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBlood-brain barrier (BBB) limits over 95% of drugs' penetration into brain, which has been a major obstacle in treating patients with glioblastoma. Transient BBB opening in glioblastoma (GBM) is feasible by combining focused ultrasound (FUS) with systemic infusion of microbubbles (MB). NaviFUS, a novel device that integrates neuronavigation and FUS-MB system, is able to intraoperatively direct the ultrasound energy precisely and repeatedly at targeted CNS areas. This clinical trial evaluates the safety and feasibility of NaviFUS in recurrent glioblastoma patients.
methodsThe study is a first-in-human, prospective, open-label, single-center, single-arm, dose escalation phase 1 clinical trial. A total of 6 patients will be enrolled. Patients will be enrolled into three groups, each group receiving an escalating dose of FUS energy (acoustic power is 4, 8, and 12 W) with concomitant systemic microbubbles (0.1 mL/kg) applied 1 week before surgical resection.
resultsDynamic contrast-enhanced MRI will be obtained immediately and 24 hours after FUS procedures, while heavily T2-weighted sequence will be obtained to evaluate for any micro-hemorrhages. We anticipate that there will be minimal side effects associated with NaviFUS-mediated transient BBB opening.
conclusionsObtained results will support a planned phase 2 trial to evaluate whether NaviFUS can effectively enhance the delivery of chemotherapeutic agents and improve tumor control.
Indexed as
Identifiers
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.