The NCITA Infrastructure is composed of three cross -institutional units and three activity groups which work in synergy to provide a coordinated infrastructure and integrated pipeline for the development of quality assured cancer imaging biomarkers for clinical use.
Imaging Clinical Trials Unit
The NCITA Imaging Clinical Trials Unit (CTU) supports and coordinates studies, where the research question focuses on imaging, or imaging is required to determine the primary end point. The CTU is a cross-institutional network of imaging centres across the UK, which provide expertise in a range of MRI, PET/CT, PET/MRI and CT imaging techniques for single and multicentre medical imaging studies.
Working closely with the NCITA QA/QC Unit and the Repository Unit, the CTU will develop robust standardised image acquisition, processing and analysis tools for the development of imaging biomarkers, from first-in-human application to achieving single-site reproducibility assessment. The CTU will also support multi-centre clinical studies required for standardisation and potential certification of imaging biomarkers.
The NCITA CTU is directed by Professor Dow-Mu Koh (Institute of Cancer Research, London) and Professor Stuart Taylor (UCL), and managed by the CTU Manager Dr Nicola Muirhead based at UCL and integrated with the UCL BRC Imaging Trials Unit.
The statistical collaborator and advisor is Sue Mallett, Professor in Diagnostic and Prognostic Medical Statistics, University College London, Centre for Medical Imaging.
The NCITA Quality Assurance and Quality Control Unit (QA/QC Unit) aims to convert imaging biomarkers from undefined lab-based metrics into locked down, quality assured clinical imaging toolkits . The unit provides robust validation, standardisation, quality assurance and quality control methods for the development of imaging biomarkers from first-in-human studies to achieving multi-site reproducibility assessment.
The QA/QC unit is a cross-institutional unit which works in conjunction with the NCITA Repository Unit and CTU to leverage the core strengths in medical imaging techniques and chemistry of our NCITA partners, including University of Manchester, King’s College London, Imperial College, London and The ICR.
QA/QC activities include evidence assessment, technical validation, biological validation with clinical samples, single centre repeatability, multi-centre reproducibility and staged imaging biomarker lock down (image acquisition and processing),
The NCITA QA/QC Unit is directed by Professor Eric Aboagye (Imperial College London).
The NCITA Repository Unit provides an image repository and data management service for secure storage of imaging biomarker trial data and sharing of anonymised datasets between trials sites in multicentre clinical trials. The repository is based on a comprehensive platform for secure archiving, processing and sharing of research imaging data previously developed by the CRUK Cancer Imaging Centres (CIC) initiative.
The Repository Unit will develop the platform to provide a sustainable repository for storage, processing and sharing of clinical imaging trial datasets for NCITA Exemplar studies, as well as data sharing with external academic and industrial partners. Over the course of the 5-year CRUK Accelerator award, the NCITA Repository Unit will also work to develop the platform to enable data clearance for release as a community resource, making possible the linking of curated imaging datasets to publications and generation of datasets for artificial intelligence research.
The Repository Unit is directed by Professor Evis Sala (University of Cambridge) and managed by the Repository Unit Manager Dr Simon Doran (Institute of Cancer Research, London).
The NCITA Engagement Group facilitates the NCITA infrastructure through engagement with imaging biomarker consumers (NHS, pharma, academic institutions, patient groups) and service providers (medical imaging, nuclear medicine and medical data management companies). The Engagement Group, in conjunction with the Governance Group, are establishing a Consensus Group of key stakeholders to agree quality assurance characteristics for the validation and certification of imaging biomarkers for clinical use and adoption into the NHS; the results of which will be published in a Consensus paper.
The Engagement Group disseminates NCITA news, events and information through the NCITA website, social media, press releases and publications. The Engagement Group also facilitates new industrial, academic and clinical collaborators to access NCITA infrastructure support for clinical imaging biomarker validation studies, and Big Data research using imaging biomarker readouts.
The NCITA Training Group are continuing the educational training initiated by the CRUK Cancer Imaging Centres (CICs) by training the next generation of cancer imaging scientists through the organisation of regular training events and an annual national NCITA Conference. The Training Group support the NCITA network by developing bespoke training workshops relevant to the Exemplar projects, or projects adopted by the NCITA infrastructure.
The NCITA Training Group are also developing a platform of online teaching materials for NCITA staff as well as the broader cancer imaging community.
The NCITA Training Group is directed by Professor James O’Connor (Institute of Cancer Research and University of Manchester) and managed by the NCITA Training and Communication Manager Ms Elizabeth Openshaw (University of Manchester).
Contracts Management Group
The NCITA Contracts Management Group is responsible for managing and completing all contracts required to meet NCITA’s strategic priorities. This includes the overarching collaboration agreements between the NCITA partner institutions and Cancer Research UK, as well contracts with external commercial and academic partners for studies adopted through the NCITA study adoption process.
The Contracts Management Group is developing a template study contract for collaborating institutions to reduce start-up times for multicentre clinical studies and improve study efficiency. The group includes contract management representatives from the 7 NCITA funded partner institutions and may also include, on an ad hoc basis, external commercial and non-partner academic contract representatives as required.
NCITA Exemplar Projects
NCITA is supporting a portfolio of Exemplar projects in areas of unmet clinical need to demonstrate the effectiveness of the NCITA infrastructure in accelerating the standardisation and clinical translation of cancer imaging biomarkers.
NCITA leaders work closely with the Cancer Research UK Commercial Partnerships team to establish the best commercial model to ensure new discoveries from the Exemplar projects and other projects supported by Cancer Research UK become available to patients with cancer.
Investigation of short-chain fatty acid uptake in solid tumours by [
18F] fluoropivalate (FPIA) PET and its relationship with tumour proliferation in GLIOMA and other cancers
Validation of hyperpolarised [1,4-
2] fumarate as a candidate for prognostic and treatment response marker for RENAL cancer
Establishing the environment for UK multicentre clinical evaluation of whole-body (WB) MRI as a diagnostic and treatment response marker in MULTIPLE MYELOMA
Oxygen enhanced magnetic resonance imaging for patients with lung cancer receiving chemoradiation
Exosome analysis of HER2 expression and heterodimerisation in patients from the HERPET study at Imperial College London
Adoption of Clinical Imaging Research Studies
NCITA is collaborating with clincial researchers across the UK to provide NCITA Repository, Imaging Clinical Trials Unit and QA/QC Unit support for multicentre clinical imaging biomarker studies.
NCITA infrastructure support is available to external partners from both academia and industry, provided the clinical research proposal meets the NCITA study eligibility criteria.
External Studies Adopted by the NCITA Infrastructure
NeuroSAFE PROOF Trial
A single blinded, multi-centre, feasibility study to evaluate the ability to randomise men with prostate cancer into a trial comparing NeuroSAFE Robotic assisted radical prostatectomy (RALP) to standard Robotic assisted radical prostatectomy (RALP).
NCITA Imaging Clinical Trials Unit, NCITA Repository Unit
Comparison of diagnostic ccuracy of Luminal Index and Multi-parametric MRI for Accelerated deTEction of significant prostate cancer
NCITA Imaging Clinical Trials Unit, QA/QC Unit, Repository Unit
Assessment of diagnostic and prognostic VALue, identification of bIological correlates, and Determination of TEchnical performance of novel metabolic and microstructural MRI in PROstate cancer
NCITA Imaging Clinical Trials Unit, Repository Unit
Lutathera and ASTX727 in Neuroendocrine Tumours
NCITA Imaging Clinical Trials Unit