NCT03551249 is a NA clinical trial of Focused ultrasound (FUS) in Glioma, sponsored by InSightec.

Who is sponsoring NCT03551249?

NCT03551249 is sponsored by InSightec.

What drugs are being tested in NCT03551249?

Interventions in NCT03551249: Focused ultrasound (FUS).

What condition does NCT03551249 study?

NCT03551249 studies Glioma, Glioblastoma.

Is NCT03551249 still recruiting?

NCT03551249 is currently completed. Last updated 20 March 2026.

Last reviewed 2026-03-20 · How we verify

NCT03551249

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption

Completed NA Last updated 20 March 2026

What this trial tests

NA trial testing Focused ultrasound (FUS) in Glioma in 20 participants. Completed in 31 December 2023.

Timeline

26 March 2019

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	InSightec
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	26 March 2019
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	4 locations across United States

Drugs / interventions tested

Focused ultrasound (FUS)

Conditions studied

Glioma — all drugs for Glioma →
Glioblastoma — all drugs for Glioblastoma →

Sponsor

InSightec — full company profile →

Who can join

Adults 18 to 80, any sex, with Glioma or Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the safety of the ExAblate Model 4000 Type 2 used as a tool to disrupt the BBB (blood brain barrier) in patients with high grade glioma undergoing standard of care therapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
Advances in local therapy for glioblastoma - taking the fight to the tumour.
van Solinge TS, Nieland L, Chiocca EA, Broekman MLD. · · 2022 · cited 219× · PMID 35277681 · DOI 10.1038/s41582-022-00621-0
Glioblastoma Therapy: Past, Present and Future.
Obrador E, Moreno-Murciano P, Oriol-Caballo M, López-Blanch R, et al · · 2024 · cited 147× · PMID 38473776 · DOI 10.3390/ijms25052529
Localized blood-brain barrier opening in infiltrating gliomas with MRI-guided acoustic emissions-controlled focused ultrasound.
Anastasiadis P, Gandhi D, Guo Y, Ahmed AK, et al · · 2021 · cited 122× · PMID 34504017 · DOI 10.1073/pnas.2103280118
Opening of the Blood-Brain Barrier Using Low-Intensity Pulsed Ultrasound Enhances Responses to Immunotherapy in Preclinical Glioma Models.
Sabbagh A, Beccaria K, Ling X, Marisetty A, et al · · 2021 · cited 113× · PMID 34031054 · DOI 10.1158/1078-0432.ccr-20-3760
Theranostic Strategy of Focused Ultrasound Induced Blood-Brain Barrier Opening for CNS Disease Treatment.
Chen KT, Wei KC, Liu HL. · · 2019 · cited 108× · PMID 30792657 · DOI 10.3389/fphar.2019.00086
Applications of focused ultrasound-mediated blood-brain barrier opening.
Gorick CM, Breza VR, Nowak KM, Cheng VWT, et al · · 2022 · cited 95× · PMID 36272635 · DOI 10.1016/j.addr.2022.114583
Towards controlled drug delivery in brain tumors with microbubble-enhanced focused ultrasound.
Schoen S, Kilinc MS, Lee H, Guo Y, et al · · 2022 · cited 68× · PMID 34801617 · DOI 10.1016/j.addr.2021.114043

Verify or expand the search:

Other recruiting trials for Glioma

Currently open trials in the same condition.

NCT07486713 — Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies · Phase 4 · recruiting
NCT07236840 — Self-administered Remote Neurological Examination Using Mobile Application in Patients With Brain Tumors · recruiting
NCT07450872 — Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms in Childhood Cancer Survivors · recruiting
NCT07405372 — Construction and Application of an IDH Mutation-Targeted PET/MRI Imaging Framework for Precision Diagnosis of Gliomas · recruiting
NCT07338539 — BIO-SHORT: Biologically Guided Short-Course Hypofractionated RT for Poor-Prognosis GBM · Phase 2 · recruiting

Other InSightec trials

Trials by the same sponsor.

NCT04667715 — Safety and Effectiveness of Blood-Brain Barrier Disruption (BBBD) in Subjects With Suspected Infiltrating Glioma · NA · withdrawn
NCT05539196 — A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advance · recruiting
NCT05089786 — Echo-Focusing in Patients With Treatment-Resistant Neurologic and Psychiatric Indications (EF001) · NA · unknown
NCT05565443 — MR-guided Focused Ultrasound Plus GCase · NA · recruiting
NCT05317858 — Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03551249 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by InSightec
Last refreshed: 20 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03551249.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing