Medical Imaging for Drug Development

Invicro is an imaging CRO with over 200 scientists, 70+ PhD’s and MD’s and 1500+ qualified imaging centers across the globe. We possess scientific and regulatory expertise, project management scale and operational excellence to manage all the medical imaging components of your Phase I-IV clinical trials across the therapeutic spectrum. Our imaging core lab technology platforms support key decision-making in drug development by utilizing:

  • Site training and data harmonization
  • Patient screening and eligibility
  • Criteria-based centralized independent reviews and internal analysis
  • Confirmation of disease to ensure accurate patient management
  • Late-stage, multi-center determination of efficacy
  • Radiotracer supply chain and dose management capabilities

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Imaging Core Lab - Complete Project Support

Study Design

Deep scientific and medical expertise to support your study design

Study Start-Up

Investigator meeting, site training and qualification, and documentation creation/development

Image Mgmt.

Image submission and quality control via iPACS® – 21 CFR Part 11 Compliant

Read Mgmt.

Images are queued for subspeciality readers (blinded reads) – 21 CFR Part 11 Compliant

Image Analysis

Our team translates sophisticated, cutting-edge analytics into validated Core Lab workflows

Data Mgmt.

Data delivery via common formats including CDISC and study specific reporting

Imaging Core Lab Expertise

Oncology

Invicro’s imaging core lab offers criteria-driven reads for standard-of-care projects and our state of the art in-house software enables 3D region-of-interest generation to support quantitative analysis methods, such as PERCIST. We also partner with subspecialist independent readers that focus on specific areas of expertise.

Validated Criteria Examples

    • RECIST 1.0/1.1
    • PCWG 2.0/3.0
    • RANO
    •  LUGANO
    • IMWG
    • CHESON

Modified for Immuno-oncology

    • iRECIST
    • irRECIST
    • LYRIC
    • irRC

Neurology

  • 300+ clinical imaging trials managed
    • >150 AD and PD Studies with >36,000 subjects imaged
  • 50+ large, multi-center trials conducted with PET, SPECT and MRI modalities
    • 1600+ imaging centers qualified worldwide
  • Two “in-house”clinical imaging centers with PET, SPECT and MRI capabilities
    • Development and application of 90+ novel neuro imaging agents
  • Redefining imaging analytic techniques
    • Amyloid, Tau and Dat IQ Analytics
    • SUV Generation
    • Centiloid Mapping

Reader Programs

Invicro partners with leading institutions to select subspecialty radiologists, neuroradiologists and oncologists for our reader programs. We have a dedicated team that qualifies and selects readers to ensure that we have the most experienced professionals available to meet your study needs. All readers are trained according to your specific project requirements and performance is routinely monitored. Reads can be performed either as rolling reads as time points come in or batched and read as subjects come off study.

 

Different types of reads include:

  • Eligibility
    • 24-72 hour turnaround
  • Confirmation of progression
    • 24-72 hour turnaround
  • Safety
  • Double Read + Adjudication
  • Double Read + Adjudication + Oncologist Clinical Read
  • Consensus
  • Majority

Medical Image Analysis

Invicro’s Medical Image Analysis team specializes in the evaluation of images to assess the performance of therapeutic and diagnostic agents. With more than 25,000,000 DICOM images analyzed, we have the expertise and scale to efficiently manage these processes to reduce variability and comply with regulatory requirements. At Invicro, image science meets image engineering. Our industry leading Image Analysis team translates sophisticated, cutting-edge analytics into validated Core Lab workflows, including:

Quantitative Oncology

The medical image analysis team supports standard analysis of FDG PET imaging, including PERCIST and other SUV-based metrics, metabolic tumor volume and total lesion glycolysis. The image analysis team also specializes in developing and applying a broad range of tools to support advanced quantitative oncology tracer characterization and analytics across a broad range of modalities and studies. Examples include:

  • Powerful, multi-modal tumor and organ Segmentation tools
  • A range of flexible Biomathematical Modeling tools
  • Dosimetry calculations across radionuclide, administration route and species
  • Integrated Radiomics pipelines using standard and custom feature vectors
  • Preclinical and clinical support for Tracer Characterization
  • Sophisticated batch Image Triage and preprocessing methods

 

For more information, check out some of our most popular case studies. A full list is also available in our case studies section!

Dosimetry Analysis

Radiomics

Biodistribution

Multi-Modality – Oncology

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Neurology

The image analysis team provides industry-leading tools for Neuro PET, SPECT and MRI analysis supporting quantification projects from discovery research through late phase trials. Invicro’s teams have analyzed thousands of clinical scans for Alzheimer’s Disease studies, utilizing validated SUVR pipelines, Centiloids and the state-of-the-art AmyloidIQ and TauIQ algorithms for Amyloid imaging and Tau imaging, respectively. Examples include:

  • The novel IQ Analytics suite for Tau Imaging, Amyloid Imaging and DaT Imaging
  • A range of flexible Biomathematical Modeling tools
  • Validated pipelines across multiple quantitative outcomes
  • Preclinical and clinical support for Tracer Characterization
  • Sophisticated batch Image Triage and preprocessing methods

 

For more information, check out some of our most popular case studies. A full list is also available in our case studies section!

Amyloid Load

Dosimetry Analysis

Tracer Kinetic Analysis

Learn More

Modalities

Invicro’s imaging core lab is supported by iPACS®, our state-of-the-art image management platform. Utilizing a modality agnostic workflow to intake imaging data, we can QC, analyze and read a variety of imaging modalities, including:

PET/SPECT

Invicro is an industry leader in managing Phase I-IV clinical trials utilizing PET & SPECT imaging to support trial objectives. Our expertise includes:

  • Imaging protocol development by Invicro scientists, physicians and industry key opinion leaders
  • 1000+ PET qualified imaging centers in 35+ countries and 150+ SPECT qualified imaging centers in 15+ countries
  • Phantom analysis algorithms for site instrument assessment and performance metrics
  • Use of our internally developed iPACS software platform for fully web-based data submission, incorporating real-time conformity checks, configurable and automated study-specific workflows, and integrated query module
  • Real-time image data review by modality experts for adherence to imaging guidelines and site-specific approved parameters for data standardization and harmonization
  • Global network of expert radiologists and nuclear medicine physicians for study eligibility determination and drug efficacy assessments
  • Automated pipelines for objective, quantitative analysis of radiotracer distribution and localization fully validated for compliance regulatory guidelines

MRI

Invicro has extensive expertise in conducting clinical MRI exploratory, disease modification and patient phenotyping/segregation studies.

  • Three in-house, state-of-the-art systems for advanced MRI in our London clinic
  • 300+ MRI qualified imaging sites in 25+ countries
  • Centers are required to acquire ACR MRI phantom data using specific to characterize scanner performance
  • Patient protocols are established and utilized for validation
  • Our team of scientists are also actively engaged in trials with novel modalities and techniques such as resting-state fMRI, phMRI, MRS, DCE-MRI, ALS-MRI

Others

Invicro’s imaging core lab supports a variety of additional modalities including:

  • CT
  • NM Bone Scan
  • Echo
  • X-ray, including Dynamic X-ray
  • Photography
  • Ultrasound

 

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