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NCT06329570
Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)
Phase 1, PHASE2 trial testing NaviFUS System in Glioblastoma Multiforme in 10 participants. Currently enrolling.
31 December 2027
Quick facts
| Lead sponsor | NaviFUS Corporation |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 22 October 2024 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 March 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- NaviFUS System
- Lumason — full drug profile →
- Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
Conditions studied
- Glioblastoma Multiforme — all drugs for Glioblastoma Multiforme →
- Glioblastoma — all drugs for Glioblastoma →
- Glioma — all drugs for Glioma →
- Brain Tumor — all drugs for Brain Tumor →
Sponsor
NaviFUS Corporation — full company profile →
Who can join
18 and older, any sex, with Glioblastoma Multiforme or Glioblastoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This will be a prospective, open-label, single-arm pilot study to investigate the safety and efficacy of Bevacizumab (BEV) in combination with microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care (SoC) in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Angiogenesis in Glioblastoma-Treatment Approaches.
Nowacka A, Śniegocki M, Smuczyński W, Bożiłow D, et al · · 2025 · cited 20× · PMID 40136656 · DOI 10.3390/cells14060407 -
CAR-T cell therapy in brain malignancies: obstacles in the face of cellular trafficking and persistence.
Yaacoub S, Vannoy E, Maslova S, Haffey A, et al · · 2025 · cited 6× · PMID 40612954 · DOI 10.3389/fimmu.2025.1596499 -
Clinical Trials of Focused Ultrasound for Brain Tumors.
Lu VM, Niazi TN. · · 2025 · cited 3× · PMID 39941880 · DOI 10.3390/cancers17030513 -
MR Imaging-Guided Focused Ultrasound-Clinical Applications in Managing Malignant Gliomas.
Chen H, Anastasiadis P, Woodworth GF. · · 2024 · cited 3× · PMID 39322356 · DOI 10.1016/j.mric.2024.05.006 -
Ultrasound targeted microbubbles for theranostic applications in liver diseases: from molecular imaging to targeted therapy.
Zhang C, Zhang Q, Xu Q, Jiang X, et al · · 2025 · cited 2× · PMID 40771132 · DOI 10.1080/10717544.2025.2541656
Verify or expand the search:
- PubMed search for NCT06329570
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of NaviFUS System
Trials testing the same drug.
- NCT07274787 — Safety And Effectiveness Of NaviFUS System With Bevacizumab In Recurrent Glioblastoma · NA · not yet recruiting
- NCT06388707 — A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Dr · Phase 1, PHASE2 · recruiting
- NCT05947656 — Evaluation of the NaviFUS System in Drug Resistant Epilepsy · NA · recruiting
- NCT04999046 — NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy · NA · completed
- NCT04988750 — Evaluate the Safety and Preliminary Efficacy of the Combination of NaviFUS System With Re-irradiation for rGBM Patients · NA · completed
Other recruiting trials for Glioblastoma Multiforme
Currently open trials in the same condition.
- NCT06466031 — Application of FET-PET in Fusion With MRI in the Treatment of Glioblastoma Multiforme [TYR-GLIO] · NA · recruiting
- NCT06333899 — Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion · EARLY_PHASE1 · recruiting
- NCT05956821 — Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age · Phase 1, PHASE2 · recruiting
- NCT06496971 — A Prospective Pivotal Study to Evaluate the Efficacy and Safety of Avastin® Bevacizumab (BEV) With or Without Microbubbl · Phase 3 · recruiting
- NCT06585527 — Clinical Study on the Safety and Efficacy of TS-2021 in the Treatment of Recurrent Malignant Glioma · Phase 1 · recruiting
Other NaviFUS Corporation trials
Trials by the same sponsor.
- NCT06496971 — A Prospective Pivotal Study to Evaluate the Efficacy and Safety of Avastin® Bevacizumab (BEV) With or Without Microbubbl · Phase 3 · recruiting
- NCT06388707 — A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Dr · Phase 1, PHASE2 · recruiting
- NCT06492720 — A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Re · NA · recruiting
- NCT04999046 — NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy · NA · completed
- NCT04988750 — Evaluate the Safety and Preliminary Efficacy of the Combination of NaviFUS System With Re-irradiation for rGBM Patients · NA · completed
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 NCT06329570 (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 NaviFUS Corporation
- Last refreshed: 9 April 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/NCT06329570.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing