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Detection and Staging of Liver Fibrosis by Precise MRI (pMRI)

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42AA025863-02
Agency Tracking Number: R42AA025863
Amount: $1,333,342.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NIAAA
Solicitation Number: PA17-303
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-01
Award End Date (Contract End Date): 2021-06-30
Small Business Information
5075 LAKE FJORD PASS, Marietta, GA, 30068-1641
DUNS: 078419511
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: N
Principal Investigator
 (404) 413-5520
Business Contact
Phone: (404) 429-1434
Research Institution
 PO BOX 3999
ATLANTA, GA, 30302-3999
 Nonprofit college or university
Abstract Chronic liver injury due to alcoholmetabolic dysfunctionviral hepatitisor autoimmune disease results in liver inflammation and fibrosisLiver fibrosis will progress to cirrhosis which is estimated to affectof the world s populationThe major clinical consequences of cirrhosis are liver failure and hepatocellular carcinomaHCCboth of which increase the risk of deathAlcoholic liver diseaseALDis a leading cause of liver disease and liver related deaths globallyparticularly in developed nationsThe current gold standard diagnostic methodliver biopsyhas many limitations including sampling error and high inter observer variability with aerror rate even for the diagnosis of advanced stages of liver fibrosisIn additionliver biopsy is an invasivepainful and expensive procedure with the risk of complications involving hospitalization and mortalityLiver biopsy is therefore of limited use for screening or monitoring disease progressionNone of several technologies investigated offers the desired sensitivity and specificity for the detection or staging of fibrosisThe novel contrast agent developed in our laboratoryProCACollagencombined with innovative processing techniques made possible by this agentpromise to significantly enhance the precision of MRI in diagnosing and monitoring liver fibrosisWe have successfully met all of the proposed aims and milestones for Phase I to obtain proof of principle evidence to achieve early detection of liver fibrosis with significantly improved sensitivity and selectivityWe have demonstrated that ProCACollagen detects in vivo liver fibrosis in mouse modelsIn this Phase II projectwe will optimize affinity for collagen binding and biodistribution and validate in vivo capability in the early detection and staging of liver fibrosisWe will obtain essential data required for filing IND applications leading to clinical translation Narratives It is especially important to develop reliable noninvasive methods to monitor patients at risk for liver fibrosisA highly effective MRI contrast agent and improved image processing will allow accurate detection of fibrosis at early stagesmonitoring of liver fibrosis progression and response to treatmentWhen identified in an early or moderate stage liver fibrosis can be arrested by ceasing alcohol consumptionThe contrast agent can later be applied to many types of fibrotic diseases

* Information listed above is at the time of submission. *

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