Evidence map›Paper›PMID 30674905›Full record

ArticleScientific reports2019

Blood-Brain Barrier Opening in Primary Brain Tumors with Non-invasive MR-Guided Focused Ultrasound: A Clinical Safety and Feasibility Study.

Todd Mainprize, Nir Lipsman, Yuexi Huang, Ying Meng, Allison Bethune, Sarah Ironside, Chinthaka Heyn, Ryan Alkins, Maureen Trudeau, Arjun Sahgal and 2 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Scientific reports, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04446416 (An Open Label, Prospective, Pilot Study to Evaluate the Efficacy and Safety of Best Physician's Choice of Standard of Care Combined With NaviFUS System in Patients With Recurrent Glioblastoma Multiforme), which is not on this map. Cited by 336 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
336citing papers in PubMed, 4 pooled it
30.6field-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.

NCT04446416 nacompletednot on this mapstarted 2020, after this paper: background citation

An Open Label, Prospective, Pilot Study to Evaluate the Efficacy and Safety of Best Physician's Choice of Standard of Care Combined With NaviFUS System in Patients With Recurrent Glioblastoma Multiforme

TypeinterventionalSponsorNaviFUS CorporationRan2020 to 2023Enrolled6ConditionsGlioblastoma Multiforme, Glioblastoma, Glioma, Brain TumorArmsNaviFUS System, Bevacizumab
3 · Its place in the literature

Who cites it

336 citing papers in PubMed, 4 syntheses or guidelines pooled it, 581 citations in OpenAlex.

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  16. Focused ultrasound for brain metastases.Neuro-oncology advances · 2026
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276 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

12 authors at 2 institutions in 1 country.

Todd MainprizeDivision of Neurosurgery, Sunnybrook Health Sciences Centre, Toronto, Canada. todd.mainprize@sunnybrook.ca.
Nir LipsmanDivision of Neurosurgery, Sunnybrook Health Sciences Centre, Toronto, Canada.
Yuexi HuangSunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Canada.
Ying MengDivision of Neurosurgery, Sunnybrook Health Sciences Centre, Toronto, Canada.ORCID 0000-0003-3180-2404
Allison BethuneHurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, Canada.
Sarah IronsideOdette Cancer Centre, Sunnybrook Research Institute, Toronto, Canada.
Chinthaka HeynDepartment of Medical Imaging, Sunnybrook Health Sciences Centre, Toronto, Canada.
Ryan AlkinsDivision of Neurosurgery, Queen's University, Kingston, Canada.
Maureen TrudeauOdette Cancer Centre, Sunnybrook Research Institute, Toronto, Canada.
Arjun SahgalOdette Cancer Centre, Sunnybrook Research Institute, Toronto, Canada.
James PerryOdette Cancer Centre, Sunnybrook Research Institute, Toronto, Canada.
Kullervo HynynenSunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Canada.
Sunnybrook Health Science Centre · CAQueen's University · CA

Funding

Ultrasound Therapy Delivery Through Intact SkullR01EB003268 · NIBIB · SUNNYBROOK & WOMEN'S COLL HLTH SCIS CTR · PI HYNYNEN, KULLERVO · 2003 to 2020
$8.2M
NIBIB NIH HHS R01 EB003268
6 · The paper itself

Abstract

The blood-brain barrier (BBB) has long limited therapeutic access to brain tumor and peritumoral tissue. In animals, MR-guided focused ultrasound (MRgFUS) with intravenously injected microbubbles can temporarily and repeatedly disrupt the BBB in a targeted fashion, without open surgery. Our objective is to demonstrate safety and feasibility of MRgFUS BBB opening with systemically administered chemotherapy in patients with glioma in a phase I, single-arm, open-label study. Five patients with previously confirmed or suspected high-grade glioma based on imaging underwent the MRgFUS in conjunction with administration of chemotherapy (n = 1 liposomal doxorubicin, n = 4 temozolomide) one day prior to their scheduled surgical resection. Samples of "sonicated" and "unsonicated" tissue were measured for the chemotherapy by liquid-chromatography-mass spectrometry. Complete follow-up was three months. The procedure was well-tolerated, with no adverse clinical or radiologic events related to the procedure. The BBB within the target volume showed radiographic evidence of opening with an immediate 15-50% increased contrast enhancement on T1-weighted MRI, and resolution approximately 20 hours after. Biochemical analysis of sonicated versus unsonicated tissue suggest chemotherapy delivery is feasible. In this study, we demonstrated transient BBB opening in tumor and peritumor tissue using non-invasive low-intensity MRgFUS with systemically administered chemotherapy was safe and feasible. The characterization of therapeutic delivery and clinical response to this treatment paradigm requires further investigation.

Indexed as

AdultAgedAnimalsAntineoplastic AgentsBlood-Brain BarrierBrain NeoplasmsDoxorubicinDrug TherapyFeasibility StudiesFemaleGliomaHumansMagnetic Resonance ImagingMaleMiddle AgedMolecular Targeted TherapyAntineoplastic AgentsDoxorubicinliposomal doxorubicinPolyethylene GlycolsTemozolomide

Identifiers

PMID30674905
PMCPMC6344541
OpenAlexW2921121152

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.