Study Phase: <span>Phase II</span>

Augmented MRI Endpoints in a Phase II Crohn’s Program

Augmented MRI Endpoints in a Phase II Crohn’s Program

Adding functional motility metrics to a Phase II Crohn's imaging protocol to sharpen the read on treatment response.

icon Gastroenterology
Additive EndpointMRIPhase II
In this case study
    Study details
    PublishedNovember 2024
    Therapy AreasGastroenterology
    Endpoint typeAdditive Endpoint
    ModalityMRI
    Study phasePhase II
    01 — Situation

    The scientific question behind the program.

    This case study outlines an early-phase imaging challenge and the endpoint strategy Fidēs designed to answer the biological question at hand. Replace this with the program-specific narrative.

    02 — Our Approach

    Designing imaging endpoints around the biology.

    Fidēs aligned the imaging strategy with the study’s decision points, implementing quantitative measures appropriate to the indication and modality.

    03 — Impact

    Clearer, earlier decisions.

    The approach delivered a richer, more sensitive read-out to support the go / no-go decision. Replace with the measured outcome.

    More From Fidēs

    Other case studies

    icon Gastroenterology
    The Role of Movement in Characterising Treatment Response in IBD

    Augmenting standard MRI endpoints with motility measures to deliver a more complete characterisation of biological response in Crohn's disease.

    Read case study
    icon Gastroenterology
    The Power of Movement: Motion as an Imaging Endpoint

    Augmenting standard MRI endpoints with motility measures to deliver a more complete characterisation of biological response in Crohn's disease.

    Read case study
    icon Gastroenterology
    Structural and Functional MRI Assessment in Post-Surgical J-Pouch Patients

    Combining structural and functional MRI to characterise pouch function and inflammation in post-surgical J-pouch patients.

    Read case study
    icon Oncology
    Uterine Contractility as a Quantitative Endpoint in Early-Phase Gynaecology Trials

    Establishing uterine contractility as a quantitative, reproducible imaging endpoint for early-phase gynaecology trials.

    Read case study
    icon Oncology
    Beyond RECIST: Additive Imaging Endpoints in Solid Tumour Trials

    How augmented endpoint analysis provides earlier and more interpretable signals than standard volumetric measures alone.

    Read case study
    icon Oncology
    Live Data Visibility in Phase I Imaging Trials

    A review of how real-time imaging access changes sponsor behaviour and supports earlier go / no-go decisions in early development.

    Read case study
    icon Gastroenterology
    Augmented MRI Endpoints in a Phase II Crohn’s Program

    Adding functional motility metrics to a Phase II Crohn's imaging protocol to sharpen the read on treatment response.

    Read case study
    icon Gastroenterology
    Cine-MRI Motility Analysis as a Primary Endpoint

    Using cine-MRI motility analysis as a primary endpoint to detect functional change earlier than structural measures alone.

    Read case study
    Work With Us

    Ready to discuss
    your study?

    Whether you are early in study design or scoping an imaging partner for an upcoming trial, we are happy to have a no-obligation conversation about your program.

    Get in Touch Get in Touch
    Structural and Functional MRI Assessment in Post-Surgical J-Pouch Patients

    Structural and Functional MRI Assessment in Post-Surgical J-Pouch Patients

    Combining structural and functional MRI to characterise pouch function and inflammation in post-surgical J-pouch patients.

    icon Gastroenterology
    StructuralMRIPhase II
    In this case study
      Study details
      PublishedJanuary 2025
      Therapy AreasGastroenterology
      Endpoint typeStructural
      ModalityMRI
      Study phasePhase II
      01 — Situation

      The scientific question behind the program.

      This case study outlines an early-phase imaging challenge and the endpoint strategy Fidēs designed to answer the biological question at hand. Replace this with the program-specific narrative.

      02 — Our Approach

      Designing imaging endpoints around the biology.

      Fidēs aligned the imaging strategy with the study’s decision points, implementing quantitative measures appropriate to the indication and modality.

      03 — Impact

      Clearer, earlier decisions.

      The approach delivered a richer, more sensitive read-out to support the go / no-go decision. Replace with the measured outcome.

      More From Fidēs

      Other case studies

      icon Gastroenterology
      The Role of Movement in Characterising Treatment Response in IBD

      Augmenting standard MRI endpoints with motility measures to deliver a more complete characterisation of biological response in Crohn's disease.

      Read case study
      icon Gastroenterology
      The Power of Movement: Motion as an Imaging Endpoint

      Augmenting standard MRI endpoints with motility measures to deliver a more complete characterisation of biological response in Crohn's disease.

      Read case study
      icon Gastroenterology
      Structural and Functional MRI Assessment in Post-Surgical J-Pouch Patients

      Combining structural and functional MRI to characterise pouch function and inflammation in post-surgical J-pouch patients.

      Read case study
      icon Oncology
      Uterine Contractility as a Quantitative Endpoint in Early-Phase Gynaecology Trials

      Establishing uterine contractility as a quantitative, reproducible imaging endpoint for early-phase gynaecology trials.

      Read case study
      icon Oncology
      Beyond RECIST: Additive Imaging Endpoints in Solid Tumour Trials

      How augmented endpoint analysis provides earlier and more interpretable signals than standard volumetric measures alone.

      Read case study
      icon Oncology
      Live Data Visibility in Phase I Imaging Trials

      A review of how real-time imaging access changes sponsor behaviour and supports earlier go / no-go decisions in early development.

      Read case study
      icon Gastroenterology
      Augmented MRI Endpoints in a Phase II Crohn’s Program

      Adding functional motility metrics to a Phase II Crohn's imaging protocol to sharpen the read on treatment response.

      Read case study
      icon Gastroenterology
      Cine-MRI Motility Analysis as a Primary Endpoint

      Using cine-MRI motility analysis as a primary endpoint to detect functional change earlier than structural measures alone.

      Read case study
      Work With Us

      Ready to discuss
      your study?

      Whether you are early in study design or scoping an imaging partner for an upcoming trial, we are happy to have a no-obligation conversation about your program.

      Get in Touch Get in Touch
      The Role of Movement in Characterising Treatment Response in IBD

      The Role of Movement in Characterising Treatment Response in IBD

      Augmenting standard MRI endpoints with motility measures to deliver a more complete characterisation of biological response in Crohn's disease.

      icon Gastroenterology
      Motility & MovementMRIPhase II
      In this case study
        Study details
        PublishedFebruary 2025
        Therapy AreasGastroenterology
        Endpoint typeMotility & Movement
        ModalityMRI
        Study phasePhase II
        01 — Situation

        The scientific question behind the program.

        This case study outlines an early-phase imaging challenge and the endpoint strategy Fidēs designed to answer the biological question at hand. Replace this with the program-specific narrative.

        02 — Our Approach

        Designing imaging endpoints around the biology.

        Fidēs aligned the imaging strategy with the study’s decision points, implementing quantitative measures appropriate to the indication and modality.

        03 — Impact

        Clearer, earlier decisions.

        The approach delivered a richer, more sensitive read-out to support the go / no-go decision. Replace with the measured outcome.

        More From Fidēs

        Other case studies

        icon Gastroenterology
        The Role of Movement in Characterising Treatment Response in IBD

        Augmenting standard MRI endpoints with motility measures to deliver a more complete characterisation of biological response in Crohn's disease.

        Read case study
        icon Gastroenterology
        The Power of Movement: Motion as an Imaging Endpoint

        Augmenting standard MRI endpoints with motility measures to deliver a more complete characterisation of biological response in Crohn's disease.

        Read case study
        icon Gastroenterology
        Structural and Functional MRI Assessment in Post-Surgical J-Pouch Patients

        Combining structural and functional MRI to characterise pouch function and inflammation in post-surgical J-pouch patients.

        Read case study
        icon Oncology
        Uterine Contractility as a Quantitative Endpoint in Early-Phase Gynaecology Trials

        Establishing uterine contractility as a quantitative, reproducible imaging endpoint for early-phase gynaecology trials.

        Read case study
        icon Oncology
        Beyond RECIST: Additive Imaging Endpoints in Solid Tumour Trials

        How augmented endpoint analysis provides earlier and more interpretable signals than standard volumetric measures alone.

        Read case study
        icon Oncology
        Live Data Visibility in Phase I Imaging Trials

        A review of how real-time imaging access changes sponsor behaviour and supports earlier go / no-go decisions in early development.

        Read case study
        icon Gastroenterology
        Augmented MRI Endpoints in a Phase II Crohn’s Program

        Adding functional motility metrics to a Phase II Crohn's imaging protocol to sharpen the read on treatment response.

        Read case study
        icon Gastroenterology
        Cine-MRI Motility Analysis as a Primary Endpoint

        Using cine-MRI motility analysis as a primary endpoint to detect functional change earlier than structural measures alone.

        Read case study
        Work With Us

        Ready to discuss
        your study?

        Whether you are early in study design or scoping an imaging partner for an upcoming trial, we are happy to have a no-obligation conversation about your program.

        Get in Touch Get in Touch