Mount Sinai BioMedical Engineering and Imaging Institute Center for Imaging Clinical Trials
Trusted by Industry. Powered by Science. Driving the Future of Imaging and Multimodal Data Acquisition, Analysis, and Integration in Clinical Trials.
Executive Summary The Center for Imaging Clinical Trials (CICT) at the Mount Sinai BioMedical Engineering and Imaging Institute (BMEII) is a premier academic-industry research partner specializing in advanced imaging for clinical trials. We combine the rigor of a world-class academic medical center with the operational excellence of a clinical research organization (CRO).
Why Industry Partners Choose Us Regulatory Credibility Imaging biomarkers validated in NIH- and FDA-reviewed trials Proven Track Record More than 200 active imaging trials across cardiovascular, oncology, neurology, and metabolic disease Trusted by Leaders Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Bracco Diagnostics, Daiichi Sankyo, GE, GlaxoSmithKline, Guerbet, Merck, Pfizer, Regeneron, Roche, Novartis, Siemens Healthineers, Takeda
Cutting-edge infrastructure MRI, PET/MR, PET/CT, CT, and more than 3 PB of secure imaging storage Future-ready analytics AI-enabled image processing, wearable integration, and multimodal data fusion
Resources and Capabilities Research-Dedicated Human Imaging Systems • MRI: Siemens Skyra 3T, Prisma 3T, Sola 1.5T, Magnetom 7T • PET/CT and PET/MR: Biograph Vision PET/CT, Biograph mMR PET/MR
Mount Sinai Imaging Research Warehouse The Mount Sinai Imaging Research Warehouse is a secure, large-scale repository of multimodal imaging data linked with rich clinical, molecular, and digital health information from across the Mount Sinai Health System. It provides an unparalleled environment for data-driven discovery, biomarker validation, and trial optimization.
• CT: Siemens Force Dual-Energy, Siemens Naeotom Alpha Photon Counting CT
Key Features
• Additional: DEXA, Ultrasound,
• Multimodal integration: Imaging paired with genomics, proteomics, metabolomics, and wearable device data
SPECT, X-ray
Research-Dedicated Preclinical Imaging Systems
• Scale: Over 22 million imaging exams (MRI, CT, PET, ultrasound, X-ray) linked with longitudinal EHR data
• Secure and compliant: HIPAA-compliant infrastructure with governance for academic and industry collaboration. • AI-ready: Data structured and curated for advanced analytics, machine learning, and deep learning models
• Micro MRI: Bruker 7T, Bruker 9.4T • Micro PET/CT: Mediso nano PET/CT • Biolumenescence/Fluorescence: IVIS Spectrum • Micro Ultrasound: VisualSonics Vevo 2200
High-Performance Computing and AI • Four NVIDIA DGX-series AI servers for large-scale imaging and deep learning • Virtual computing clusters and >3 PB secure storage • Regulatory-grade pipelines for rapid, reproducible, and compliant image analysis
Seamless Cross-Modality Integration • Biorepository, metabolomics, neuropathology, stem cell engineering, flow cytometry • -omics, digital biomarkers, and wearables as well as with other Mount Sinai core facilities.
With over 200 active clinical trials and partnerships across pharma, biotech, and MedTech, BMEII-CICT is your trusted partner for imaging, multimodal data acquisition, analysis, and integration innovation, regulatory-grade trial execution, and next-generation biomarkers. – Bachir Taouli, MD, MHA Director, Cancer and Body Imaging Clinical Trials Unit
Integration and Specialization The BMEII–CICT comprises image analysts, postdocs, computer scientists, clinical and research faculty with experience in basic research and clinical translation. Leveraging this expertise, CICT faculty are able to assist in design and implementation of all aspects of imaging-based clinical trials from state-of-the-art acquisition protocols, data transfer and QC, image analysis, and reporting. As an academic center, our faculty work with academic and industry partners to develop bespoke imaging solutions for particular needs offering development, testing, validation, and protocol implementation. Our faculty also offer experience in adapting workflows to adhere to the principles of part 11 compliance for industry partners. BMEII–CICT also offers specialization in cardiovascular imaging, cancer and body imaging, and neuroimaging domains.
Cardiovascular Imaging Clinical Trials Unit (C-ICTU)
Cancer and Body Imaging Clinical Trials Unit (CB-ICTU)
Neuroimaging Clinical Trials Unit (N-ICTU)
The CICTU functions as a specialized imaging CRO with academic rigor, designing and executing cardiovascular imaging trials for pharma, biotech, and device sponsors.
Since 2013, CB-ICTU has been a trusted imaging partner for oncology clinical research at the NCI-designated Tisch Cancer Institute Mount Sinai.
N-ICTU partners with pharma and MedTech to design and deliver advanced brain imaging endpoints that align with trial objectives.
To date the C-ICTU has participated in several large NIH and pharmasponsored multi-center clinical trials including the CIRT imaging study (NCT02576067), the dal-PLAQUE study (NCT00655473), the TARGET trial (NCT02374021), and MATADOR (ACTRN12625000273482, Australia). The C-ICTU has also been the core imaging and image analysis lab for numerous phase 2 clinical trials with industry partners.
Core Services
• Structural MRI: segmentation, regional and sub-regional volumetrics
Capabilities • PET/CT, PET/MR, cardiac MRI, dual-energy CT • Comprehensive cardiac MRI: LV function, strain, tissue characterization • Vascular inflammation imaging: World leader in 18F-FDG PET/CT/ MR endpoints • Whole-body body composition imaging for cardiometabolic and cachexia studies
• Tumor response assessments (RECIST, mRECIST, irRECIST, PERCIST) • Advanced imaging: diffusion, perfusion, elastography, volumetry • Imaging-guided tissue sampling and intratumoral injections • Whole-body MRI for cancer screening and longitudinal monitoring
Capabilities
• Quantitative parametric MRI: T1/ T2/T2* mapping, QSM • Vascular and perfusion MRI: SWI, ASL, TOF, quantification of perivascular spaces • Diffusion imaging: DTI, NODDI, tractography, structural connectivity • Functional MRI: task activation, resting-state functional connectivity, brain and spinal cord • Metabolic MRI: spectroscopy, CEST • Predictive AI: brain age quantification • Additional metrics can be implemented upon request.
Digital Twin Study Platform BMEII is pioneering a Digital Twin Study Platform that integrates advanced imaging, multiomics, wearables, and AI to create individualized patient “digital twins.” These twins serve as predictive models of health and disease, offering sponsors a powerful tool for drug development and trial optimization.
Core Features
Industry Value
• Imaging-anchored twins: MRI, PET/CT, and CT biomarkers form the foundation of patientspecific models
• De-risk development: Simulate patient outcomes before trial enrollment to refine inclusion criteria and endpoints
• Data fusion: Integration of multiomics (genomics, proteomics, metabolomics), wearable sensors, and clinical data
• Accelerate timelines: Use validated surrogate biomarkers for earlier go/no-go decisions
• AI-powered simulations: Predict treatment response, disease progression, and trial outcomes
• Enable precision medicine: Identify patient subgroups most likely to benefit from investigational therapies
• Remote monitoring: Incorporates decentralized trial elements such as at-home devices, e-consent, and real-time data capture
• Regulatory innovation: Partner with BMEII to advance acceptance of digital twin-derived biomarkers
“
BMEII’s Digital Twin Platform transforms traditional trials into predictive, patient-centric studies—helping sponsors move faster, smarter, and with greater confidence. – Zahi A. Fayad, PhD Director, BioMedical Engineering and Imaging Institute
Collaboration Models We offer flexible engagement models to meet diverse sponsor needs:
1 2 3 4
Full-Service CRO Mode End-to-end imaging support: protocol design ➜ central reading ➜ regulatory submissions
Modular Services Standalone services: QC, analysis, site training, data transfer
Co-Development Partnerships Joint development of biomarkers, AI pipelines, and endpoints
Academic-Industry Alliances Early-phase exploratory studies leveraging NIH/foundation funding
Our Leadership Team Zahi A. Fayad, PhD Director, BioMedical Engineering and Imaging Institute Director, Cardiovascular Imaging Clinical Trials Unit
Bachir Taouli, MD, MHA Director, Cancer and Body Imaging Clinical Trials Unit
Priti Balchandani, PhD Director, Neuroimaging Clinical Trials Unit
Contact Us Interested in partnering on your next imaging-enabled trial? Contact our leadership team to explore tailored engagement models. Mount Sinai BioMedical Engineering and Imaging Institute Icahn School of Medicine at Mount Sinai 1470 Madison Avenue New York, NY 10029
bmeii-trials@mssm.edu bmeiisinai.org/trials