# Tumor bed implant for simultaneous heat and radiation of resectable brain tumors

> **NIH NIH R41** · MAE CONSULTING GROUP LLC · 2020 · $300,000

## Abstract

Abstract / Summary
Glioblastoma multiforme (GBM) is an aggressive brain tumor that generally recurs locally and has a median
survival <18 months. Treatment typically involves surgery followed by radiation and chemotherapy but the
challenge remains to provide sufficient radiation dose to sterilize tumor bed without unacceptable toxicity in
surrounding normal brain. A randomized clinical trial studying brachytherapy radiation boost to tumor bed with
and without sequentially applied local heat showed a doubling of two-year survival in GBM compared to
brachytherapy alone. Although that 31% two-year survival rate is higher than current state of the art treatment
approaches for GBM, previous thermobrachytherapy studies used University prototype heating systems that
were never commercialized, and thus the approach was discontinued. With alternative treatments still failing to
match prior results, the time has come to optimize thermobrachytherapy. Ensuing in vivo studies have shown
that synergy between heat (HT) and radiation (RT) is maximized when the two therapies are applied
simultaneously. To meet the urgent need for improved survival following brain tumor surgery, we propose a
dual-modality thermobrachytherapy (TBT) balloon implant to fill the resection cavity and further increase the
survival benefit seen in prior studies by: i) delivering HT and RT more uniformly to tumor bed; ii) providing
potent thermal enhancement of RT response up to 5X in tumor bed by combining HT and RT simultaneously;
iii) beginning RT of tumor bed immediately after surgery before tumor cell migration; and iv) improving patient
satisfaction and reducing cost by decreasing treatment time from 3-6 weeks of daily external beam RT to <5
days total therapy. Our premise is that by applying local heat and brachytherapy simultaneously for maximum
synergy and uniformly to the resection cavity wall for effective localization of effect before tumor cells migrate,
we can significantly enhance local response and survival while minimizing peripheral toxicity and thereby
improve clinical outcomes. Our Phase I development has three specific aims: i) to fabricate a dual-therapy
balloon device; ii) to evaluate the device for compatibility of HT and RT components and characterize thermal
and radiation dosimetry in laboratory studies; and iii) demonstrate appropriate heat distributions that coincide
with computer treatment plans in in vivo animal perfused tissue studies. After demonstrating safety and
effectiveness in followup clinical trials in Phase II, we anticipate neurosurgeons and oncologists associated
with ~250 brain surgery centers already owning HDR afterloaders will embrace this new technology due to
obvious need for improved therapy in >52,000 resected brain tumors annually in the US, impressive clinical
precedent in GBM with inferior thermobrachytherapy approaches, and established regulatory pathway for
component technologies. While this development is focused towards brain tumor ...

## Key facts

- **NIH application ID:** 9907105
- **Project number:** 1R41CA239815-01A1
- **Recipient organization:** MAE CONSULTING GROUP LLC
- **Principal Investigator:** Paul Rath Stauffer
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $300,000
- **Award type:** 1
- **Project period:** 2020-07-01 → 2021-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9907105

## Citation

> US National Institutes of Health, RePORTER application 9907105, Tumor bed implant for simultaneous heat and radiation of resectable brain tumors (1R41CA239815-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9907105. Licensed CC0.

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