Comparing two ways to deliver medicine directly into the brain for recurrent high‑grade glioma
Official title: Comparison of convection enhanced delivery systems in a randomized controlled clinical study of recurrent Grade 3-4 glioma patients
Funded at Creosalus, INC. · NIH-11176927 · Data updated 2026-11-12
This compares a new porous brain infusion catheter plus planning software to a standard end‑port catheter to deliver more medication into tumors for people with recurrent grade 3–4 glioma.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Creosalus, INC. NIH-funded |
| Lab location | 1 site (Louisville, United States) |
| Project start | September 1, 2024 |
| Project end | August 31, 2027 |
| Funding year | 2025 |
| Award (this year) | $682,122 |
| NIH project number | 5R44CA295197-02 |
| Project ID | NIH-11176927 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are adults with recurrent Grade 3 or Grade 4 glioma (including glioblastoma) who are medically eligible for convection‑enhanced neurosurgical catheter infusion.
✕Less likely to help
Patients with low‑grade gliomas, non‑enhancing tumors, those who are not candidates for neurosurgery, or people with unrelated medical conditions are unlikely to benefit from this intervention.
What this research studies
If I had recurrent high‑grade glioma, this project would randomly assign patients to receive drug delivery through either a new porous brain infusion catheter (PBIC) paired with molecular flow planning software, or a standard end‑port convection‑enhanced delivery catheter. The team will use FDA‑cleared infusion planning software to map and predict how drugs distribute in the tumor and surrounding brain. Doctors will measure how much of the enhancing tumor is covered by the infused medication and monitor safety outcomes. The company has preclinical data showing greater drug spread with the PBIC and will run a randomized controlled comparison in people to confirm those findings.
Why it matters
Potential benefit: If successful, this could increase how much of a tumor receives locally delivered therapy and possibly improve treatment effects for people with recurrent high‑grade glioma.
How similar studies have gone: Preclinical animal studies and infusion modeling have shown increased distribution with the PBIC and the planning software is FDA 510(k)‑cleared, but randomized human comparisons of catheter designs are novel.
Where this research is happening
-
Creosalus, INC.
Louisville, United States Active
Researchers
- Principal investigator: Abramov, Vasiliy — Creosalus, INC.
- Study coordinator: Abramov, Vasiliy
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.