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HYPMED Report Summary

Project ID: 667211
Funded under: H2020-EU.3.1.

Periodic Reporting for period 1 - HYPMED (Digital Hybrid Breast PET/MRI for Enhanced Diagnosis of Breast Cancer)

Reporting period: 2016-01-01 to 2017-06-30

Summary of the context and overall objectives of the project

HYPMED will develop and evaluate a new device for breast PET/MRI hybrid imaging. The project will integrate an innovative, fully digital MRI-transparent PET-detector directly into a novel, fully PET-transparent breast MRI surface coil. With the resulting PET-RF insert, we will allow precision imaging of breast cancer by truly combining unprecedented high-resolution and ultra-low dose dedicated breast positron emission tomography (PET) with highest level structural and multi-parametric functional MR imaging.
The need for improved methods for cancer diagnosis is ever-increasing in parallel with the increasing demands of personalized medicine. The concept of targeted therapies requires not only knowing about the presence or absence of cancer, but also an in-depth analysis of a given cancer to select and guide appropriate treatment. PET and MRI are diagnostic tools that provide functional and molecular information that is of pivotal importance for such treatment concepts. However, current approaches to PET/MR imaging lack the necessary sensitivity that is essential for the type of information needed to guide tailored therapies. HYPMED will use a novel PET-RF insert to identify imaging correlates of molecular processes that are specific for carcinogenesis, i.e. of tissue mechanisms that stimulate and maintain cancer growth, cancer metabolic homeostasis, and metastatic potential of cancers.
The specific project objectives are:
• Technical development of a dedicated ultra-low-dose, ultra-high-sensitivity, PET-RF insert with integrated vacuum biopsy capability as the ultimate tool for breast cancer diagnosis
• Development and evaluation of quantitative PET-MRI acquisition, image reconstruction, post-processing and visualization methods for the targeted application of breast cancer
• Establish the clinical use and diagnostic utility of the novel PET-RF insert
• Correlation of multiparametric functional imaging information with established and novel tissue-based biomarkers
By working towards these objectives we want to introduce a paradigm shift in the field of hybrid PET/MR imaging as a whole. Once the concept of a combined PET-RF insert for breast imaging proves successful, we plan to expand this approach to other clinical applications e.g. prostate, cardiac hybrid imaging, and hybrid imaging of the abdomen or extremities. With such dedicated integrated PET-RF inserts, any conventional clinical MR-system can be used as a full-range hybrid system that allows one to exploit the full potential of simultaneous highest-level PET and MR imaging in a targeted fashion.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

In the first period work focussed on the mechanical design of the PET-RF insert, the development of the required software implementations, preparatory work for the clinical validation of the device, initial studies for tissue biomarkers. Additionally, dissemination activities were performed to raise awareness for HYPMED`s innovative solutions and to engage with the end user community.
The design of the insert mechanics was completed and served as a solid basis for the design of the high sensitive radiofrequency coil and the development of the MR-compatible PET detector modules. Technical challenges related to the down-scaling of the developed RF-coil and MR-compatible PET detector technology were solved. Good progress was also made in terms of software implementations that are needed to operate the device. All required system adaptations and software changes for MR fingerprinting were established. After successful implementation of the sequence and reconstruction, MR fingerprinting can now be further adapted to clinical needs. A first MR-based attenuation correction was computed and promising results for image processing were obtained. The exploration of the clinical use of the PET-RF insert and its diagnostic utility will be done by multi-centre study which will start in the third year of the project. In period 1 preparatory patient studies for the development of the multi-modality image processing software have successfully been conducted. Additionally, the preliminary drafts of the study protocol, patient information and Informed Consent Form and documents for ethical approval were prepared. For the correlation of multiparametric functional imaging information with established and novel tissue-based biomarkers a control series of different breast lesions has been generated to define different types of immune infiltrate and other components of the tumour microenvironment. The major part of this work will be conducted in the third year of the project.
In terms of dissemination a stakeholder database of 300 contacts was developed. A project website has been established ( and almost 2000 website visitor sessions were recorded since the start of the project. A first project newsletter introducing the project and highlighting the first achievements of the mechanical design of the PET-RF insert was published in project month 12. Project promotional and information material was produced and distributed at five medical imaging conferences. In terms of exploitation the market structure is currently being evaluated by conducting a market analysis for PET/MRI. Overall the HYPMED project is on good track and consortium partners are confident to achieve the project`s objectives in the forthcoming periods.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

HYPMED develops a breast PET-RF insert with a more than twofold increase in sensitivity and resolution and the capability to perform PET- and MRI-guided biopsy. Due to the high sensitivity and low radiation dose involved, it will be indicated for many more clinical applications than ever before. The concept of HYPMED will greatly increase the availability of this technique, and, thus patients’ access to high-level molecular and functional breast imaging.
The accuracy and reliability of the non-invasive detection of breast cancer and of the delineation of its extent will be significantly improved. Beyond the mere diagnosis of presence or absence of breast cancer, we will improve the non-invasive biological classification of breast cancers, i.e. improve the assessment of its aggressiveness, in order to improve appropriate treatment selection.
The expected improved prediction of response, response assessment and prognostication in patients undergoing therapy will allow an earlier adaption in case of treatment failure. Based on the innovative PET-RF insert, HYPMED will enable a more accurate and early diagnosis of breast cancer and will provide new imaging biomarkers that are needed to guide local and systemic treatment of breast cancer. Moreover, the HYPMED approach can be translated to other areas.
The introduction the breast PET-RF insert will reduce the overall economic costs associated with breast cancer and pave the way for similar developments in prostate cancer, cardiac imaging, brain and abdominal imaging among others, bolstering the sustainability of the European healthcare system. The successful completion of HYPMED will unlock a new market that is estimated to amount to €100 million per year. In the beginning, this market will be exclusively served by the industry partners participating in the project. Extending the concept will to cardiac and prostate imaging will enlarge the market size to estimated €300 million per year.

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