
Vascular CT Contrast Agent DevelopmentAward last edited on: 5/22/2023
Sponsored Program
SBIRAwarding Agency
NIH : NHLBITotal Award Amount
$1,915,423Award Phase
2Solicitation Topic Code
837Principal Investigator
Michael A DavisCompany Information
Phase I
Contract Number: 1R44HL152877-01Start Date: 9/1/2020 Completed: 7/31/2021
Phase I year
2020Phase I Amount
$249,980Public Health Relevance Statement:
Project Narrative We will develop an urgently needed blood pool tantalum-based vascular CT contrast agent that dramatically improves CT imaging of vascular disease, particularly in patients with obesity, atherosclerotic disease, metallic implants, and inability to tolerate currently available iodinated contrast agents. To bring this agent to clinical use, we will define scale-up processes for contrast agent synthesis, perform required good laboratory practice preclinical toxicity tests, then obtain first-in-human Clinical Phase 1 tests.
Project Terms:
absorption; acute toxicity; Address; Adipose tissue; Adverse event; Algorithms; American; Angiography; Animal Model; Animals; Appearance; Atherosclerosis; Award; base; Biological; biomaterial compatibility; Blood; Blood Vessels; Canis familiaris; Cardiovascular Diseases; cardiovascular risk factor; Characteristics; Clinical; clinical translation; Clinical Trials; Color; commercialization; contrast enhanced; contrast imaging; Contrast Media; Data; Development; Distant; Documentation; Dose; drug development; Drug Kinetics; Effectiveness; efficacy testing; Excretory function; experience; extracellular; Family suidae; first-in-human; Formulation; Frequencies; Goals; good laboratory practice; Human; Hypersensitivity; Image; imaging agent; imaging capabilities; Implant; improved; In Vitro; in vivo; Individual; Industry; Injections; Injury to Kidney; Intercellular Fluid; intraperitoneal; Intraperitoneal Injections; Intravenous; Iodine; Kidney; metallicity; Metals; Methods; Modality; Morphologic artifacts; nanoparticle; Obesity; Operative Surgical Procedures; Organ; Patient imaging; patient population; Patients; Phase; phase 1 testing; Phase II/III Trial; Plasma; Population; pre-clinical; preclinical safety; preclinical toxicity; Prevalence; Process; Property; prototype; Radiology Specialty; Rattus; Recovery; Reproducibility; Research; Research Personnel; Risk; risk minimization; Roentgen Rays; Route; Safety; safety testing; Sales; scale up; Scanning; Severities; Signal Transduction; Small Business Innovation Research Grant; small molecule; stability testing; Stents; Structure; Syncope; Tantalum; Testing; Time; Tissues; Toxic effect; Toxicity Tests; Trauma patient; Vascular calcification; Vascular Diseases; Venous; volunteer; Work; X-Ray Computed Tomography
Phase II
Contract Number: 4R44HL152877-02Start Date: 9/1/2020 Completed: 7/31/2023
Phase II year
2021(last award dollars: 2022)
Phase II Amount
$1,665,443Public Health Relevance Statement:
Project Narrative We will develop an urgently needed blood pool tantalum-based vascular CT contrast agent that dramatically improves CT imaging of vascular disease, particularly in patients with obesity, atherosclerotic disease, metallic implants, and inability to tolerate currently available iodinated contrast agents. To bring this agent to clinical use, we will define scale-up processes for contrast agent synthesis, perform required good laboratory practice preclinical toxicity tests, then obtain first-in-human Clinical Phase 1 tests.
Project Terms: