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NCT05733312
Extracellular Impact of Ultrasound-induced Blood-brain Barrier Disruption
NA trial testing InSightec's ExAblate Neuro Model 4000 Type 2.0 (220 KHz) system in Brain Tumor in 6 participants. Currently enrolling.
15 January 2027
Quick facts
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 6 |
| Start date | 24 January 2024 |
| Primary completion | 15 January 2027 |
| Estimated completion | 15 January 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- InSightec's ExAblate Neuro Model 4000 Type 2.0 (220 KHz) system
Conditions studied
- Brain Tumor — all drugs for Brain Tumor →
Sponsor
Mayo Clinic
Who can join
18 and older, any sex, with Brain Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study seeks to determine the impact of focused ultrasound (FUS) on the composition of the tumor extracellular microenvironment. Researchers will evaluate regions that are very abnormal, as well as regions that have less evidence of disease. A sub-portion of each of these areas will be targeted by focused ultrasound. Microdialysis catheters will then be placd into each region that has and has not been exposed to FUS (total of 4 catheters) to determine how FUS impacts the the brain and tumor extracellular metabolome, including concentration of routine drugs systemically administered prior to, and during surgery. Researchers hope that this information will help reveal the relative contribution of blood-derived compounds to the tumor microenvironment. If successful, microdialysis could be leveraged in the future to simultaneously evaluate pharmacokinetic and pharmacodynamic impacts of future candidate therapies, including those delivered with the aid of FUS.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Focused ultrasound-mediated enhancement of blood-brain barrier permeability for brain tumor treatment: a systematic review of clinical trials.
Zhu H, Allwin C, Bassous MG, Pouliopoulos AN. · · 2024 · cited 34× · PMID 39207625 · DOI 10.1007/s11060-024-04795-z -
Consensus review on strategies to improve delivery across the blood-brain barrier including focused ultrasound.
Piper K, Kumar JI, Domino J, Tuchek C, et al · · 2024 · cited 15× · PMID 38770775 · DOI 10.1093/neuonc/noae087 -
Fundamentals and Applications of Focused Ultrasound-Assisted Cancer Immune Checkpoint Inhibition for Solid Tumors.
Jahangiri S, Yu F. · · 2024 · cited 7× · PMID 38543305 · DOI 10.3390/pharmaceutics16030411 -
Translational strategies and systems biology insights for blood-brain barrier opening and delivery in brain tumors and Alzheimer's disease.
Song G, Plumlee P, Ahn JY, Wong ST, et al · · 2023 · cited 7× · PMID 37703663 · DOI 10.1016/j.biopha.2023.115450 -
Clinical Trials of Focused Ultrasound for Brain Tumors.
Lu VM, Niazi TN. · · 2025 · cited 3× · PMID 39941880 · DOI 10.3390/cancers17030513 -
Regulation of the brain tumor microenvironment by focused ultrasound.
Fu K, Hu H, Zhou X, Li L, et al · · 2025 · cited 2× · PMID 40520576 · DOI 10.1016/j.omton.2025.200994
Verify or expand the search:
- PubMed search for NCT05733312
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05733312 (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 Mayo Clinic
- Last refreshed: 30 January 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/NCT05733312.
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