Center for Imaging Clinical Trials

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

Research-Dedicated Human Imaging Systems

• MRI: Siemens Skyra 3T, Prisma 3T, Sola 1.5T, 7T ultra-high field
• PET/CT and PET/MR: Biograph Vision PET/CT, Biograph mMR PET/MR
• CT: Siemens Force Dual-Energy, Siemens Naeotom Alpha Photon Counting CT
• Additional: DEXA, Ultrasound, SPECT, X-ray

Research-Dedicated Preclinical Imaging Systems

• 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

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.

Key Features

• Scale: Over 13 million imaging exams (MRI, CT, PET, ultrasound, X-ray) linked with longitudinal EHR data
• Multimodal integration: Imaging paired with genomics, proteomics, metabolomics, and wearable device 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

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.

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.

The CICTU functions as a specialized imaging CRO with academic rigor, designing and executing
cardiovascular imaging trials for pharma, biotech, and device sponsors.

To date, the C-ICTU has participated in several large NIH and pharma-sponsored 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.

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

Since 2013, CB-ICTU has been a trusted imaging partner for oncology clinical research at the
NCI-designated Tisch Cancer Institute Mount Sinai.

Core Services
• 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

N-ICTU partners with pharma and MedTech to design and deliver advanced brain imaging endpoints that align with trial objectives.

Capabilities

• Structural MRI: segmentation, regional and sub-regional volumetrics
• 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.

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

• Imaging-anchored twins: MRI, PET/CT, and CT biomarkers form the foundation of patient specific models
• Data fusion: Integration of multiomics (genomics, proteomics, metabolomics), wearable sensors, and clinical data
• AI-powered simulations: Predict treatment response, disease progression, and trial outcomes
• Remote monitoring: Incorporates decentralized trial elements such as at-home devices, e-consent, and real-time data capture

Industry Value

• De-risk development: Simulate patient outcomes before trial enrollment to refine inclusion
  criteria and endpoints
• Accelerate timelines: Use validated surrogate biomarkers for earlier go/no-go decisions
• Enable precision medicine: Identify patient subgroups most likely to benefit from investigational therapies
• Regulatory innovation: Partner with BMEII to advance acceptance of digital twin-derived
  biomarkers

We offer flexible engagement models to meet diverse sponsor needs:

1. Full-Service CRO Mode
   • End-to-end imaging support: protocol design ➜ central reading ➜ regulatory submissions
2. Modular Services
   • Standalone services: QC, analysis, site training, data transfer
3. Co-Development Partnerships
   • Joint development of biomarkers, AI pipelines, and endpoints
4. Academic-Industry Alliances
   • Early-phase exploratory studies leveraging NIH/foundation funding

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

212-824-8492
bmeii-trials@mssm.edu