Neuroradiologist in front of brain MRI and DTI tractography monitors

Central Nervous System Imaging Core Lab

Our Central Nervous System (CNS) Imaging division provides specialized medical imaging expertise for clinical trials evaluating neurological, neurodegenerative, cerebrovascular, psychiatric, and spinal disorders. Supported by a network of more than 100 board-certified and fellowship-trained neuroradiologists, the CNS Imaging division combines deep subspecialty expertise with rigorous, standardized imaging methodologies designed to generate consistent, reproducible, and clinically meaningful data across multicenter and global studies.

Our experience encompasses the full spectrum of brain and spine disease processes, including Alzheimer's disease and other dementias, multiple sclerosis, Parkinson's and Huntington's diseases, epilepsy, stroke and cerebrovascular disease, traumatic brain injury, brain and spinal tumors (with our Oncology Imaging division), spinal cord injury, and degenerative disorders of the spine.

The CNS Imaging division supports sophisticated imaging protocols incorporating structural and functional MRI, MRA, CT and CTA, CT and MR perfusion, diffusion and diffusion tensor imaging, PET and other nuclear imaging techniques, spectroscopy, catheter angiography, and transcranial Doppler ultrasound. Intrinsic Imaging works closely with sponsors from protocol development and imaging charter design through site qualification, image acquisition standardization, quality control, centralized independent review, quantitative analysis, and final data delivery.

Particular emphasis is placed on controlling imaging variability across sites, scanners, readers, and longitudinal timepoints—an essential consideration in CNS trials where subtle changes in anatomy, lesion burden, perfusion, diffusion, metabolism, or other imaging biomarkers may provide critical evidence of disease progression or therapeutic response. Through this combination of subspecialty physician expertise, advanced imaging capabilities, and disciplined central-review methodology, Intrinsic Imaging provides sponsors with the imaging infrastructure and scientific rigor required to support complex CNS clinical development programs.

In CNS trials, imaging biomarkers such as lesion burden, perfusion, diffusion, and metabolism often serve as primary or secondary imaging endpoints. We define each biomarker in the imaging charter and measure it consistently over time, so small changes reflect true disease progression or therapeutic response.

Central Nervous System Imaging Division Highlights

Extensive experience in providing services in support of clinical trials involving the central nervous system.
100+ board-certified and fellowship-trained neuroradiologists.
Expertise includes the full spectrum of brain and spine disease processes.
Modality expertise includes:
- CT & CTA including CT perfusion
- Diffusion tensor imaging
- MRI & MRA including MR perfusion
- Nuclear imaging including FDG PET, catheter angiography with special expertise in invasive devices
- Spectroscopy
- Ultrasound including transcranial doppler

Neuroimaging Endpoints for CNS Clinical Trials

Our neuroimaging core lab supports trials in Alzheimer's disease and other dementias, multiple sclerosis, Parkinson's and Huntington's diseases, epilepsy, stroke, traumatic brain injury, brain and spinal tumors, and spinal cord injury. Endpoints may include lesion burden, structural change, perfusion, diffusion, metabolism, and other imaging biomarkers of disease progression or therapeutic response.

Advanced MRI, PET and Perfusion Imaging

Our neuroradiologists read structural and functional MRI, MRA, CT and CTA, CT and MR perfusion, diffusion and diffusion tensor imaging, spectroscopy, FDG PET and other nuclear imaging, catheter angiography, and transcranial Doppler ultrasound.

Controlling Variability in Multicenter Neuroimaging

Because subtle longitudinal change can be decisive in CNS trials, we emphasize site and scanner qualification, acquisition standardization, centralized quality control, and blinded independent central review with reader training and adjudication.

Neuroimaging Methods by Disease and Endpoint

CNS trials require methods that distinguish disease progression, treatment effects and imaging safety findings. We align sequences, tracer selection, quantitative analysis and central review with the indication and the role of each endpoint.

Indication	Methods	Assessments
Alzheimer’s disease and dementia	Structural MRI, amyloid PET, tau PET and FDG PET	Whole-brain and hippocampal volume, regional tracer uptake and longitudinal change
Anti-amyloid treatment safety	FLAIR and susceptibility-sensitive MRI	ARIA-E edema or effusion and ARIA-H microhemorrhage or superficial siderosis
Multiple sclerosis	T2/FLAIR, contrast-enhanced T1 and volumetric MRI	New or enlarging lesions, enhancing lesions and brain-volume change
ALS and motor-neuron disease	Structural MRI and diffusion tensor imaging	Regional atrophy and white-matter measures as protocol-defined exploratory biomarkers
Parkinson’s and movement disorders	MRI, dopamine-transporter SPECT and PET	Regional structure, tracer binding and protocol-defined functional measures
Stroke and cerebrovascular disease	CT/CTA, MRI/MRA and perfusion imaging	ASPECTS, infarct volume, vessel status and perfusion-defined tissue measures
Brain tumors	Contrast-enhanced MRI, diffusion and perfusion	RANO-based response, enhancing disease and non-enhancing change

ARIA Safety Review and Escalation

For anti-amyloid programs, readers assess amyloid-related imaging abnormalities using the protocol’s severity definitions and comparison timepoints. We distinguish ARIA-E from ARIA-H, document lesion location and extent, and track changes on follow-up MRI. Findings are communicated through an agreed safety-escalation process; treatment decisions remain with the investigator and sponsor.

Volumetric MRI and Molecular Imaging Biomarkers

Quantitative workflows include brain and regional segmentation, hippocampal volumetry, lesion burden, diffusion measures and PET uptake quantification. Registration, segmentation review and acquisition checks help distinguish biological change from motion, scanner differences or analysis artifacts. PET reference regions and any tracer-specific normalization methods are defined in the analysis plan.

Scanner Harmonization and Longitudinal Quality Control

We qualify scanner configurations and standardize sequences, positioning and reconstruction before enrollment. Phantom testing is used where required by the quantitative endpoint. Scanner upgrades, protocol changes and repeat examinations are documented so their effects can be considered in analysis.

Central readers follow prespecified blinding and comparison rules. Image quality, missing sequences and non-evaluable assessments are tracked alongside endpoint results. Calibration cases and adjudication support consistent reads throughout the study.

Guidance for Sponsors

Physician-authored guidance from Intrinsic Imaging on imaging endpoints and trial design.

Illustration of the human muscular system

Guidance for Sponsors · Volume 4, Issue 9 · 2026 Edition

Muscular Dystrophy: Medical Imaging in Clinical Trials

MRI has become one of the most valuable tools for measuring disease in muscular dystrophy. It shows which muscles are involved, how severely and how actively, and it can guide biopsy and monitor therapy. Since the first edition of this issue, quantitative MRI has moved from grading scales to precise fat-fraction measurement, and muscle fat fraction has been shown to predict loss of ambulation in Duchenne muscular dystrophy. With new therapies now approved, MRI is a key secondary endpoint and a candidate surrogate for future trials.

Read the article

Guidance for Sponsors · Volume 5, Issue 3 · 2026 Edition

Functional Imaging of the Dopamine Pathway

Parkinson disease is rising rapidly worldwide, and its early diagnosis remains difficult: symptoms overlap with essential tremor, drug-induced parkinsonism and the atypical parkinsonian syndromes, and routine MRI is usually normal. Functional imaging of the presynaptic dopamine pathway, with DaTscan SPECT and Fluorodopa F 18 PET, makes the loss of dopaminergic neurons visible. European regulators have qualified dopamine transporter imaging as an enrichment biomarker for early Parkinson disease trials, and it now works alongside the alpha-synuclein seed amplification assay in a new biological definition of the disease. This issue explains how these tools work and how sponsors should use them.

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Guidance for Sponsors · Volume 5, Issue 4 · 2026 Edition

Temporal Lobe Epilepsy and Volumetric MRI in Clinical Trials

Temporal lobe epilepsy caused by hippocampal sclerosis is one of the most common forms of drug-resistant focal epilepsy, and one of the most treatable when it is correctly identified. Visual reading of MRI can miss mild or bilateral hippocampal atrophy, which makes patient selection the weak link in many trials. Quantitative volumetry with FDA-cleared software, acquired on a harmonized epilepsy protocol, converts a subjective impression into a numerical biomarker. It can set inclusion thresholds, stratify severity, predict surgical outcome and, potentially, measure the effect of new drugs, ablation and neurostimulation devices.

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More guidance: Brain Tumor Imaging in Trials; Alzheimer's Neuroimaging in Trials; Traumatic Brain Injury Imaging in Trials; Contrast-Enhanced Neuroimaging in Trials

Browse all Guidance for Sponsors →

Featured Case Study

Central Nervous System

Phase II Alzheimer's Amyloid PET and MRI

55 sites
3T MRI, amyloid PET
Volumetric and visual PET endpoints

Challenge

In a Phase II Alzheimer's disease program, the trial's biomarker endpoints depended on detecting subtle changes in brain volume and amyloid burden over time. Yet the 55 participating academic and commercial imaging centers operated scanners from multiple vendors, each introducing its own measurement variability into volumetric MRI quantification and amyloid PET assessment. Without adequate control, this cross-site variability could obscure treatment-related changes and compromise interpretation of both the secondary and exploratory biomarker endpoints.

Read the case study

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Frequently Asked Questions

Which neurological indications does Intrinsic Imaging support?

Our experience includes Alzheimer's disease and its variants, multiple sclerosis, Parkinson's disease, Huntington's disease, epilepsy, stroke and cerebrovascular disease, brain tumors, traumatic brain injury, spinal disorders, schizophrenia and other conditions.

Who interprets CNS trial images?

CNS imaging is interpreted by more than 100 board-certified, fellowship-trained neuroradiologists.

Does Intrinsic Imaging support perfusion and diffusion imaging?

Yes. We support CT and MR perfusion, diffusion and diffusion tensor imaging, and spectroscopy.

Are volumetric and diffusion measures always primary endpoints?

No. They may serve as primary, secondary, safety or exploratory measures, depending on the protocol and supporting validation. We define that role and the analysis method with the sponsor before reads begin.

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