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NCT06329570

Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)

Recruiting now Phase 1, PHASE2 Last updated 9 April 2026
What this trial tests

Phase 1, PHASE2 trial testing NaviFUS System in Glioblastoma Multiforme in 10 participants. Currently enrolling.

Timeline
22 October 2024
Primary endpoint
31 December 2027
31 March 2028

Quick facts

Lead sponsorNaviFUS Corporation
PhasePhase 1, PHASE2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date22 October 2024
Primary completion31 December 2027
Estimated completion31 March 2028
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. Angiogenesis in Glioblastoma-Treatment Approaches.
    Nowacka A, Śniegocki M, Smuczyński W, Bożiłow D, et al · · 2025 · cited 20× · PMID 40136656 · DOI 10.3390/cells14060407
  2. 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
  3. Clinical Trials of Focused Ultrasound for Brain Tumors.
    Lu VM, Niazi TN. · · 2025 · cited 3× · PMID 39941880 · DOI 10.3390/cancers17030513
  4. 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
  5. 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:

Other trials of NaviFUS System

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Other recruiting trials for Glioblastoma Multiforme

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Other NaviFUS Corporation trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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