SBIR-STTR Award

Novel tetrahedron beam CT for point-of-care imaging in ear, nose and throat imaging
Award last edited on: 11/17/2023

Sponsored Program
STTR
Awarding Agency
NIH : NIBIB
Total Award Amount
$2,143,925
Award Phase
2
Solicitation Topic Code
286
Principal Investigator
Lu Wang

Company Information

Tetraimaging LLC

4320 Forest Park Avenue Suite 304
Saint Louis, MO 63108
   (314) 456-0035
   N/A
   www.tetraimaging.com

Research Institution

Washington University

Phase I

Contract Number: 1R41EB026401-01A1
Start Date: 9/30/2018    Completed: 8/31/2019
Phase I year
2018
Phase I Amount
$225,000
Point-of-care imaging is highly desired in otolaryngologic clinics for the diagnosis of ear, nose and throat (ENT) diseases including cancers. Due to limited image quality, current cone beam CT (CBCT) products act not as a substitute but rather as a complement to diagnostic Multi-slice CT (MSCT) in maxillofacial and ENT imaging. The emerging multi-source x-ray source technology suggests new designs of CT systems that may have faster imaging speed, improved image quality, reduced radiation exposure and compact geometries. Tetrahedron Beam Computed Tomography (TBCT) is a compact volumetric CT based on linear array multi- pixel x-ray sources which can produce diagnostic-quality volumetric images but in a much more compact geometry than CBCT. Through this project, we will develop and validate ENT-TBCT through the two specific aims: 1) To develop a ENT-TBCT benchtop system with an MPTEX source and linear x-ray detector array; 2) To evaluate and characterize TBCT via phantom and animal cadaver imaging. In future Phase II study, we plan to develop a clinical prototype system and perform comparative imaging studies in ENT clinics. We expect the novel office-based ENT-TBCT will become a highly effective point-of-care diagnostic imaging modality for otolaryngologic clinics, improve the quality and efficacy by supporting prompt diagnosis and treatment of ENT cancers and other diseases.

Project Terms:
Academy; Address; Advanced Development; Algorithms; American; anatomic imaging; Animals; base; Benchmarking; Cadaver; Clinic; Clinical; clinical imaging; commercial application; comparative; Complement; Computer software; cone-beam computed tomography; cost; design; detector; Development; Diagnosis; Diagnostic; Diagnostic Imaging; Diagnostic radiologic examination; Disease; Dose; Ear; Evaluation; Exposure to; Family suidae; Future; Geometry; Goals; Head; Head and neck structure; Head and Neck Surgery; Image; image guided radiation therapy; image reconstruction; imager; imaging modality; imaging study; Imaging technology; improved; Inferior; innovation; Intervention; Malignant Neoplasms; maxillofacial; Medical; Nose; Nose Cancer; novel; Operative Surgical Procedures; Otolaryngologist; Otolaryngology; Outcome; Outcomes Research; Patient-Focused Outcomes; Patients; Performance; Pharyngeal structure; Phase; phase 2 study; point of care; point-of-care diagnostics; Point-of-Care Systems; Process; prototype; Radiation; Radiation exposure; Research; Roentgen Rays; Scanning; Sinus; Slice; Small Business Technology Transfer Research; soft tissue; Soft Tissue Disorder; Source; Speed; Structure; System; Technology; Throat Cancer; Tomography, Computed, Scanners; Universities; Washington; X-Ray Computed Tomography;

Phase II

Contract Number: 2R42EB026401-02A1
Start Date: 9/30/2018    Completed: 8/31/2024
Phase II year
2022
(last award dollars: 2023)
Phase II Amount
$1,918,925

Point-of-care imaging is highly desired in otolaryngologic clinics for the diagnosis of ear, nose and throat(ENT) diseases including cancers. Due to limited image quality, current cone-beam CT (CBCT) products actnot as a substitute but rather as a complement to diagnostic Multi-slice CT (MSCT) in maxillofacial and ENTimaging. The emerging multi-source x-ray source technology suggests new designs of CT systems that mayhave faster imaging speed, improved image quality, reduced radiation exposure, and compact geometries.Tetrahedron Beam Computed Tomography (TBCT) is a compact volumetric CT based on linear array multi-pixel x-ray sources which can produce diagnostic-quality volumetric images but in a much more compactgeometry than CBCT. During Phase I study, we successfully developed a benchtop ENT-TBCT systemusing a multi-pixel thermionic emission x-ray (MPTEX) source developed in-house and a state-of-artcommercial photon-counting detector (PCD), and demonstrated the superior image quality that TBCT canachieve. During the Phase II study, we will further refine the MPTEX source and develop a clinicalprototype system. To achieve this goal, we propose to perform studies to achieve the following SpecificAims (SA): SA 1: To develop a rotatable sealed MPTEX source; SA 2: To develop a clinical ENT-TBCTprototype on a rotating gantry; and SA 3: To develop advanced image reconstruction algorithm and performbenchmark imaging studies. The outcome of this research will be a highly effective point-of-care diagnosticimaging modality for otolaryngologic clinics. Future commercialization of the ENT-TBCT system will improvethe quality and efficacy by supporting prompt diagnosis and treatment of ENT cancers and other diseases.

Public Health Relevance Statement:
NARRATIVE CT is an indispensable, first-line diagnostic imaging modality for cancers and other diseases in ear-nose- and-throat (ENT) clinics. Point-of-care imaging is crucially important in ENT clinics. During the last decade, enabled by x-ray flat-panel imager technology, cone-beam CT (CBCT) has become an important imaging modality for image-guided radiotherapy and intervention. Although several vendors have developed CBCT for ENT point-of-care imaging, the clinical usefulness of CBCT, however, is very limited due to its inferior image quality, making CBCT incompetent in the diagnosis of soft tissue diseases. In this project, we will develop a novel Tetrahedron Beam Computed Tomography (TBCT) system based on multi-pixel x-ray source technology. Unlike current CBCT that employs wider detectors to increase axial coverage, TBCT revolutionarily employs a linear x-ray source array to achieve the same coverage, thus fundamentally eliminates the inherent problems of CBCT. In this project, we will develop and commercialize the novel ENT-TBCT system for point-of-care imaging in ENT clinics. It is expected to produce superior high image quality and reduce low x-ray exposure to the patients, significantly improve the efficacy and quality of ENT clinics.

Project Terms: