Bone cancer and multiple myeloma affects over 600,000 people every year in the United States and causes progressive bone destruction that results in pain, fractures, and the inability to walk. The hypothesis of the proposal is that thermal ablation with high intensity interstitial ultrasound (HIIU) is efficacious in management of metastatic bone cancer. We propose to develop a mechanism to perform minimally invasive conformal bone ablation under combined computer tomography (CT) and CT fluoroscopy (CTF) guidance. We will prove that this method provides a consistent, reliable, and safe treatment option in a simple and cost-efficient manner. We propose classic medical technology development accomplished in two steps: first the development of appropriate core technology, and then the evaluation of that in a Phase-1 clinical trial. The deliverables of the program will be (1) an advanced prototype of an integrated medical device that is ready for regulatory approval and subsequent commercial introduction, (2) clinical methodology for the use of this device to treat metastatic spine cancer. In particular, we will apply acoustic ablative needles to be inserted percutaneously into the bone near the target. Phase-1 research will establish the feasibility of safe and accurate percutaneous HIIU needle placement and ablation under real-time quantitative CT/CTF guidance.
Specific aims are as follows:
Aim -1: Image Guidance: Develop methodology, hardware, and software components for sterotactic image guidance of the ablator device and intra-operative optimization of the ablation.
Aim -2: HIIU Applicator: Package an acoustic ablator catheter in a needle for percutaneous introduction to bony tissues, compliant to the guidance method developed in Aim-1.
Aim -3: Animal Studies: Perform feasibility studies in ex-vivo and in-vivo animal models with the system developed in Aims 1 and 2.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
5R43CA112852-02
Application #
7124707
Study Section
Special Emphasis Panel (ZRG1-SBIB-J (11))
Program Officer
Farahani, Keyvan
Project Start
2005-09-21
Project End
2008-08-31
Budget Start
2006-09-06
Budget End
2008-08-31
Support Year
2
Fiscal Year
2006
Total Cost
$183,379
Indirect Cost
Name
Acoustic Medsystems, Inc.
Department
Type
DUNS #
606222896
City
Savoy
State
IL
Country
United States
Zip Code
61874
Deshmukh, Nishikant P; Caban, Jesus J; Taylor, Russell H et al. (2015) Five-dimensional ultrasound system for soft tissue visualization. Int J Comput Assist Radiol Surg 10:1927-39
Deshmukh, Nishikant P; Kang, Hyun Jae; Billings, Seth D et al. (2014) Elastography using multi-stream GPU: an application to online tracked ultrasound elastography, in-vivo and the da Vinci Surgical System. PLoS One 9:e115881