Periodic Reporting for period 5 - HYPMED (Digital Hybrid Breast PET/MRI for Enhanced Diagnosis of Breast Cancer)
Reporting period: 2021-03-01 to 2022-06-30
The project achieved the following objectives:
• Development of a dedicated ultra-low-dose, ultra-high-sensitivity, PET–RF insert for double-breast hybrid PET-MR imaging and with integrated vacuum biopsy capability
• Development of quantitative PET-MRI acquisition, image reconstruction, post-processing and visualization methods for the targeted application of breast cancer
• “Head-to-head” comparison of the technical performance of the HYPMED device with a commercially available whole-body PET-MR system
• Collection of whole-body PET-MRI datasets of 367 patients with well-described breast cancer
• Identification of candidate immune-histochemical and genomic/epigenetic biomarkers that are representative of functional tumour features, for validation of current whole-body PET-MRI and future HYPMED-imaging findings
To test the diagnostic performance of conventional whole-body PET-MRI, 376 patients have been included, who received [18F]FGD, [18F]FMISO or [18F]choline as tracers. Histopathological specimen were shipped to enable pathological analyses. Whole-body PET-MRI data were analysed to assess diagnostic accuracy in terms of discrimination of benign and malignant lesions as well as characterization of tumour biology. All data (imaging and respective stage & histopathology information on cancers) have been stored in an anonymized database accessible to the HYPMED consortium for future comparison with the clinical performance of the HYPMED device.
The documentation and tests necessary for regulatory approval of the HYMPED device were investigated, concluding requirements for a feasibility study are very similar to those for approval for fundamental research with human subjects. Although the path for regulatory approval of the HYPMED device under the new MDR is uncertain, guidance was produced to outline the relevant norms and regulatory standards in risk management, electrical and biological safety, software and other areas, as well as design specifications and documentation of design processes. A design failure mode and effect analysis was done to identify and mitigate risks from operation, and to ensure radiation safety for patients, a specific absorption rate study conducted by NORAS, PHI and UKA was also described. The identified list of verification tests would effect a comprehensively verified system.
A tissue biobank consisting of 281 pre-invasive and invasive breast cancers and 30 normal samples was set up. For tissue biomarker development, cases were examined by conventional immunohistochemistry and by the Opal system to study relations between different cellular components and their interplay with tumour cells for correlation with whole-body PET-MR and HYPMED imaging findings.
Dissemination activities continued, and an online presence was maintained through the project website and social media. HYPMED was promoted at major congress events mostly via online formats due to COVID-19, but also onsite at ECR 2022. A dedicated HYPMED workshop held in March 2022 drew an audience of more than 270 attendees.
Moreover, the HYPMED device can be plugged into any given regular MR scanner, transferring it into a high-performance focused PET-MR hybrid system. This will substantially promote the availability of and demand for PET/MR hybrid imaging and, thus, patients’ access to high-level molecular and functional breast imaging.
Once a clinical study has established the diagnostic advantage of the HYPMED device, healthcare costs associated with breast cancer will be reduced. Moreover, the concept can be translated to other fields and could enable functional hybrid imaging of prostate cancer and cardiac, cerebral, and hepatobiliary disease, bolstering the sustainability of the European healthcare system. The successful completion of HYPMED will unlock a new market estimated to amount to €100 million/year.