Mustafa Bashir

Overview:

Hepatobiliary and pancreatic imaging
Liver cancer (hepatocellular carcinoma)
Fatty liver, NAFLD, and NASH
Chronic liver disease and cirrhosis
Pancreatic cancer
Technical development in MRI
Quantitative imaging

Positions:

Associate Professor of Radiology

Radiology, Abdominal Imaging
School of Medicine

Associate Professor in the Department of Medicine

Medicine, Gastroenterology
School of Medicine

Member of the Duke Cancer Institute

Duke Cancer Institute
School of Medicine

Education:

M.D. 2004

University of Iowa

Grants:

Imaging Core Lab for Madrigal Protocol MGL-3196-05 (A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis)

Administered By
Radiology, Abdominal Imaging
Awarded By
Madrigal Pharmaceuticals
Role
Principal Investigator
Start Date
End Date

A PHASE 2B RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF BMS-986036 (PEG-FGF21) IN ADULTS WITH NONALCOHOLIC STEATOHEPATITIS (NASH) AND STAGE 3 LIVER FIBROSIS.

Administered By
Radiology, Abdominal Imaging
Awarded By
Bristol-Myers Squibb Company
Role
Principal Investigator
Start Date
End Date

3V2640-CLIN-005 A Phase 2, Multi-Center, Single-Blind, Randomized Placebo Controlled Study of TVB-2640 in Subjects with Non-Alcoholic Steatohepatitis

Administered By
Radiology, Abdominal Imaging
Awarded By
Diabetes & Endocrinology Consultants, PC
Role
Principal Investigator
Start Date
End Date

A randomized, open label, phase 1b study to evaluate safety, PK and PD signals of DUR-928 in patients with Non-Alcoholic Steatohepatitis (NASH)

Administered By
Radiology, Abdominal Imaging
Awarded By
High Point Clinical Trial Center
Role
Principal Investigator
Start Date
End Date

A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of NGM282 Administered for 12 Weeks in Patients with Histologically Confirmed Nonalcoholic Steatohepatit

Administered By
Medicine, Gastroenterology
Awarded By
NGM Biopharmaceuticals
Role
Co-Principal Investigator
Start Date
End Date

Publications:

Multisite multivendor validation of a quantitative MRI and CT compatible fat phantom.

PURPOSE: Chemical shift-encoded magnetic resonance imaging enables accurate quantification of liver fat content though estimation of proton density fat-fraction (PDFF). Computed tomography (CT) is capable of quantifying fat, based on decreased attenuation with increased fat concentration. Current quantitative fat phantoms do not accurately mimic the CT number of human liver. The purpose of this work was to develop and validate an optimized phantom that simultaneously mimics the MRI and CT signals of fatty liver. METHODS: An agar-based phantom containing 12 vials doped with iodinated contrast, and with a granular range of fat fractions was designed and constructed within a novel CT and MR compatible spherical housing design. A four-site, three-vendor validation study was performed. MRI (1.5T and 3T) and CT images were obtained using each vendor's PDFF and CT reconstruction, respectively. An ROI centered in each vial was placed to measure MRI-PDFF (%) and CT number (HU). Mixed-effects model, linear regression, and Bland-Altman analysis were used for statistical analysis. RESULTS: MRI-PDFF agreed closely with nominal PDFF values across both field strengths and all MRI vendors. A linear relationship (slope = -0.54 ± 0.01%/HU, intercept = 37.15 ± 0.03%) with an R2 of 0.999 was observed between MRI-PDFF and CT number, replicating established in vivo signal behavior. Excellent test-retest repeatability across vendors (MRI: mean = -0.04%, 95% limits of agreement = [-0.24%, 0.16%]; CT: mean = 0.16 HU, 95% limits of agreement = [-0.15HU, 0.47HU]) and good reproducibility using GE scanners (MRI: mean = -0.21%, 95% limits of agreement = [-1.47%, 1.06%]; CT: mean = -0.18HU, 95% limits of agreement = [-1.96HU, 1.6HU]) were demonstrated. CONCLUSIONS: The proposed fat phantom successfully mimicked quantitative liver signal for both MRI and CT. The proposed fat phantom in this study may facilitate broader application and harmonization of liver fat quantification techniques using MRI and CT across institutions, vendors and imaging platforms.
Authors
Zhao, R; Hernando, D; Harris, DT; Hinshaw, LA; Li, K; Ananthakrishnan, L; Bashir, MR; Duan, X; Ghasabeh, MA; Kamel, IR; Lowry, C; Mahesh, M; Marin, D; Miller, J; Pickhardt, PJ; Shaffer, J; Yokoo, T; Brittain, JH; Reeder, SB
MLA Citation
Zhao, Ruiyang, et al. “Multisite multivendor validation of a quantitative MRI and CT compatible fat phantom.Med Phys, vol. 48, no. 8, Aug. 2021, pp. 4375–86. Pubmed, doi:10.1002/mp.15038.
URI
https://scholars.duke.edu/individual/pub1484213
PMID
34105167
Source
pubmed
Published In
Med Phys
Volume
48
Published Date
Start Page
4375
End Page
4386
DOI
10.1002/mp.15038

Week 4 Liver Fat Reduction on MRI as an Early Predictor of Treatment Response in Participants with Nonalcoholic Steatohepatitis.

Background Pharmacologic treatment of nonalcoholic steatohepatitis (NASH) is long term in nature; thus, early noninvasive treatment response assessment is important for therapeutic decision making. Purpose To investigate potential early predictors of the 12-week treatment response estimated by using the MRI-based proton-density fat fraction (PDFF). Materials and Methods In this secondary analysis of a prospective phase Ib clinical trial evaluating a candidate treatment (MET409, a farnesoid X receptor agonist) for NASH, participants were analyzed at baseline and at 4 and 12 weeks after either active treatment with MET409 or placebo treatment between June 2019 and January 2020. Correlation and multiple linear regression analyses were used to identify clinical, laboratory, and imaging predictors of the relative PDFF change at week 12 (W12). Multivariate logistic regression analysis was used to develop predictive models for an at least 30% relative PDFF reduction at W12, a well-validated indicator of histologic improvement. Model performance was characterized by using area under the receiver operating characteristic curve (AUC) analysis, sensitivity, and specificity. Results A total of 48 participants were analyzed (median age, 57 years; age range, 40-62 years; 32 women), among whom 30 received MET409 and 18 received a placebo. The week 4 (W4) relative changes in PDFF (regression coefficient = 1.24, P < .001) and the serum alkaline phosphatase (ALP) level (regression coefficient = -0.29, P = .03) were predictors of the W12 relative PDFF change. An at least 19.3% relative PDFF reduction at W4 yielded an AUC of 0.98 (sensitivity, 89%; specificity, 95%) for predicting an at least 30% relative PDFF reduction at W12. The addition of ALP to the predictive model did not improve model performance. Conclusion In participants with nonalcoholic steatohepatitis enrolled in a phase Ib treatment trial, the relative change in the MRI-based proton-density fat fraction (PDFF) at week 4 was highly predictive of the treatment response estimated by using the week 12 MRI-based PDFF. © RSNA, 2021 Online supplemental material is available for this article.
Authors
MLA Citation
Jiang, Hanyu, et al. “Week 4 Liver Fat Reduction on MRI as an Early Predictor of Treatment Response in Participants with Nonalcoholic Steatohepatitis.Radiology, vol. 300, no. 2, Aug. 2021, pp. 361–68. Pubmed, doi:10.1148/radiol.2021204325.
URI
https://scholars.duke.edu/individual/pub1484214
PMID
34060937
Source
pubmed
Published In
Radiology
Volume
300
Published Date
Start Page
361
End Page
368
DOI
10.1148/radiol.2021204325

MR Imaging of Diffuse Liver Disease.

The liver performs many vital functions for the human body. It stores essential vitamins and minerals, such as iron and vitamins A, D, K, and B12. It synthesizes proteins, such as blood clotting factors, albumin, and glycogen, as well as cholesterol, carbohydrates, and triglycerides. Additionally, it acts as a detoxifier, metabolizing and helping to clear alcohol, drugs, and ammonia. Typical MR imaging protocols for liver imaging include T2-weighted, chemical shift imaging, and precontrast and postcontrast T1-weighted sequences. This article discussed MR imaging of diffuse liver diseases and their typical imaging findings.
Authors
Marks, RM; Fowler, KJ; Bashir, MR
MLA Citation
Marks, Robert M., et al. “MR Imaging of Diffuse Liver Disease.Magn Reson Imaging Clin N Am, vol. 29, no. 3, Aug. 2021, pp. 347–58. Pubmed, doi:10.1016/j.mric.2021.05.004.
URI
https://scholars.duke.edu/individual/pub1488598
PMID
34243922
Source
pubmed
Published In
Magn Reson Imaging Clin N Am
Volume
29
Published Date
Start Page
347
End Page
358
DOI
10.1016/j.mric.2021.05.004

Data-Driven Modification of the LI-RADS Major Feature System on Gadoxetate Disodium-Enhanced MRI: Toward Better Sensitivity and Simplicity.

BACKGROUND: The Liver Imaging Reporting and Data System (LI-RADS) is widely accepted as a reliable diagnostic scheme for hepatocellular carcinoma (HCC) in at-risk patients. However, its application is hampered by substantial complexity and suboptimal diagnostic sensitivity. PURPOSE: To propose data-driven modifications to the LI-RADS version 2018 (v2018) major feature system (rLI-RADS) on gadoxetate disodium (EOB)-enhanced magnetic resonance imaging (MRI) to improve sensitivity and simplicity while maintaining high positive predictive value (PPV) for detecting HCC. STUDY TYPE: Retrospective. POPULATION: Two hundred and twenty-four consecutive at-risk patients (training dataset: 169, independent testing dataset: 55) with 742 LR-3 to LR-5 liver observations (HCC: N = 498 [67%]) were analyzed from a prospective observational registry collected between July 2015 and September 2018. FIELD STRENGTH/SEQUENCE: 3.0 T/T2-weighted fast spin-echo, diffusion-weighted spin-echo based echo-planar and three-dimensional (3D) T1-weighted gradient echo sequences. ASSESSMENT: All images were evaluated by three independent abdominal radiologists who were blinded to all clinical, pathological, and follow-up information. Composite reference standards of either histopathology or imaging follow-up were used. STATISTICAL TESTS: In the training dataset, LI-RADS v2018 major features were used to develop rLI-RADS based on their associated PPV for HCC. In an independent testing set, diagnostic performances of LI-RADS v2018 and rLI-RADS were computed using a generalized estimating equation model and compared with McNemar's test. A P value <0.05 was considered statistically significant. RESULTS: The median (interquartile range) size of liver observations was 13 mm (7-27 mm). The diagnostic table for rLI-RADS encompassed 9 cells, as opposed to 16 cells for LI-RADS v2018. In the testing set, compared to LI-RADS v2018, rLI-RADS category 5 demonstrated a significantly superior sensitivity (76% vs. 61%) while maintaining comparably high PPV (92.5% vs. 94.1%, P = 0.126). DATA CONCLUSION: Compared with LI-RADS v2018, rLI-RADS demonstrated improved simplicity and significantly superior diagnostic sensitivity for HCC in at-risk patients. LEVEL OF EVIDENCE: 3 TECHNICAL EFFICACY STAGE: 2.
Authors
Jiang, H; Song, B; Qin, Y; Wei, Y; Konanur, M; Wu, Y; Zaki, IH; McInnes, MDF; Lafata, KJ; Bashir, MR
MLA Citation
URI
https://scholars.duke.edu/individual/pub1487782
PMID
34236120
Source
pubmed
Published In
J Magn Reson Imaging
Published Date
DOI
10.1002/jmri.27824

Reduction in Fibrosis and Steatohepatitis Imaging and Biomarkers in a Phase 3 52 Week Resmetirom NASH Trial

Authors
Harrison, S; Alkhouri, N; Taub, R; Neff, G; Baum, SJ; Younes, ZH; Bashir, M
MLA Citation
Harrison, Stephen, et al. “Reduction in Fibrosis and Steatohepatitis Imaging and Biomarkers in a Phase 3 52 Week Resmetirom NASH Trial.” Journal of Hepatology, vol. 75, 2021, pp. S200–S200.
URI
https://scholars.duke.edu/individual/pub1489686
Source
wos-lite
Published In
Journal of Hepatology
Volume
75
Published Date
Start Page
S200
End Page
S200