The NCITA Infrastructure is composed of three cross -institutional units and three activity groups which work in synergy to provide an integrated pipeline for the development of quality assured cancer imaging biomarkers for clinical use.
Imaging Clinical Trials Unit
The NCITA Imaging Clinical Trials Unit supports and coordinates studies, where the research question focuses on imaging, or imaging is required to determine the primary end point. The Imaging Trials Unit 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 Imaging Clinical Trials Unit 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 Imaging Clinical Trials Unit will also support multi-centre clinical studies required for standardisation and potential certification of imaging biomarkers.
The NCITA Imaging Clinical Trials Unit is directed by Professor Dow-Mu Koh (ICR) and Professor Stuart Taylor (UCL), and managed by the NCITA Imaging Clinical Trials Unit 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 leverages the core strengths in medical imaging techniques and chemistry of NCITA partners, including University of Manchester, King’s College London, Imperial College, London and ICR, in conjunction with the NCITA Repository Unit and Imaging Clinical Trials Unit.
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 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 produce 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 opportunities and challenges.
The Repository Unit is directed by Professor Evis Sala (Cambridge University) 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 manager Ms Elizabeth Openshaw.
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.
The NCITA Contracts Management Group is directed by Professor Tony Ng (King’s College London & UCL Cancer Institute) and managed by the NCITA Contracts manager Mr Philip Ryan.
NCITA Exemplar Projects
NCITA is supporting an initial portfolio of eight Exemplar projects to demonstrate the effectiveness of the NCITA infrastructure in accelerating the validation 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 arising 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 multi-centre clinical evaluation of whole-body (WB) MRI as a diagnostic and treatment response marker in MULTIPLE MYELOMA
Establishing the multi-platform feasibility of oxygen enhanced MRI for adaptive radiotherapy planning in non-small cell LUNG CANCER
Feasibility of HER2 radionuclide imaging for stratification of BREAST CANCER patients for HER2 directed antibody-drug conjugate therapy
18F-FDOPA PET imaging in GLIOMA: feasibility study for PET guided brain biopsy
External Studies Adopted
by the NCITA Infrastructure
NCITA is collaborating with clinical researchers across the UK to provide NCITA Repository, Imaging Clinical Trials Unit and QA/QC Unit support for multicentre clinical imaging biomarker studies.
The NCITA infrastructure support is available to external partners from both academia and industry, provided the clinical research proposal meets the NCITA study eligibility criteria.
For more information on the study adoption application process, please contact us at firstname.lastname@example.org or using our contact form.
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