Periodic Reporting for period 1 - MIRACLE (MIRACLE the platform for virtual biopsies; introducing Metabolic MRI-as-a-Service for oncologic care)
Berichtszeitraum: 2022-05-01 bis 2023-04-30
Imagine a future where the limitless possibilities of virtual biopsies in cancer diagnostics can be explored. A future in which cancer patients would have access to MRI enabled virtual biopsies in order to receive the best possible treatment decisions anywhere on the globe.
MIRACLE is developing a first-of-kind add-on device for MRI scanners that will be used to acquire a virtual biopsy of the tumor providing not only structural information on tumor dimensions for (tissue
conserving) surgery, but also unique metabolic information on the efficacy of specific systemic therapies. Ultimately, this fully non-invasive, accurate and rapid predictive approach can guide patients to the best fitting treatment plan given their personal circumstances and tumor characteristics.
WaveTronica (WT) together with the University Medical Centre Utrecht (UMCU), German Cancer Research Centre (DKFZ) and Medical University of Lublin (UMLUB) aim to build this future by bringing the first Metabolic MRI-as-aService solution to the market. Past projects and research led to the development of a Proof-of-Concept MRI coil capable of detecting metabolic biomarkers non-invasively using the strongest clinically available MRI system.
The MRI coil is a plug-and-play add on for existing MRI machines resulting in an accessible and affordable virtual biopsy tool that can identify cancer biomarkers and tumor activity without shedding
a drop of patient blood. This project converts a complex research tool into an accessible diagnostic service (Metabolic MRI-as-a-Service).
MIRACLE is developing a first-of-kind add-on device for MRI scanners that will be used to acquire a virtual biopsy of the tumor providing not only structural information on tumor dimensions for (tissue
conserving) surgery, but also unique metabolic information on the efficacy of specific systemic therapies. Ultimately, this fully non-invasive, accurate and rapid predictive approach can guide patients to the best fitting treatment plan given their personal circumstances and tumor characteristics.
WaveTronica (WT) together with the University Medical Centre Utrecht (UMCU), German Cancer Research Centre (DKFZ) and Medical University of Lublin (UMLUB) aim to build this future by bringing the first Metabolic MRI-as-aService solution to the market. Past projects and research led to the development of a Proof-of-Concept MRI coil capable of detecting metabolic biomarkers non-invasively using the strongest clinically available MRI system.
The MRI coil is a plug-and-play add on for existing MRI machines resulting in an accessible and affordable virtual biopsy tool that can identify cancer biomarkers and tumor activity without shedding
a drop of patient blood. This project converts a complex research tool into an accessible diagnostic service (Metabolic MRI-as-a-Service).
Work performed on
WP1: D1.4 The Website and logo are ready and published.
WP2:
The main objective of WP2 is to fabricate fully functional RF Breast Coil prototypes
D2.1: MIRACLE work on a uniform breast coil prototype. The pre-production model is built, and the first tests are performed. The first results look promising and are in line with expectations, minor hardware adaptations must be done to finalize the RF coil design. After the modifications and completing the final tests the production phase can start.
D2.2:The RF Breast coils had not been completed at the moment of submitting this first version of this document.
D2.3: MIRACLE worked on the Development of scan protocols. The coil setup and scan protocol was adequate, as from all patients spectra could be obtained. Moreover, the tumor area could be identified in 100% of the patients.
D3.1:The objective of the deliverable D3.1 is to provide the basis for the automated evaluation pipeline for the clinical application (deliverable D3.4) which is the raw data processing and evaluation pipeline harmonized across the partner sites. This will enable consistent data reconstruction and post-processing across sites, which reduces platform-specific variations, and is required for (I) a proper assessment of inter- and intra-subject variability, and (II) the accurate definition of steps for potential improvements in signal-to-noise ratio. Due to delays in the hiring process, including the training period, so far only steps 1 & 2 are being performed. The definition of a suitable data processing format and strategy, as well as implementation of necessary tools in MATLAB, are currently ongoing.
D3.2: The objective of the deliverable D3.2 is to provide optimal outcome of the metabolic pulse sequences based on the data post-processing established in deliverable D3.1. This will improve the biomarker detection. Because deliverable D3.2 requires parts of deliverable D3.1 that are still due, none of the work has been performed so far.
D4.1: WP4 addresses the primary clinical objective of MIRACLE: perform a multi-centre prospective cohort study in breast cancer patients assessing the effectiveness of MIRACLE in executing virtual biopsies and predicting the efficacy of neo- adjuvant chemotherapy. A procedure for enabling the use of non-CE labeled devices for a clinical study has been established in The Netherlands. Also the clinical study setup details have been discussed globally with all sites. Due to the Dutch governmental decision effectuated in Nov 2022, mammocare has been centralized and no longer takes place in the UMC Utrecht. This required more established results before studies can take place that effect the treatment of the patients.
Because of the more stringent requirements for proof of patient benefit, we established an independent single site study in the envisioned breast cancer population.
WP1: D1.4 The Website and logo are ready and published.
WP2:
The main objective of WP2 is to fabricate fully functional RF Breast Coil prototypes
D2.1: MIRACLE work on a uniform breast coil prototype. The pre-production model is built, and the first tests are performed. The first results look promising and are in line with expectations, minor hardware adaptations must be done to finalize the RF coil design. After the modifications and completing the final tests the production phase can start.
D2.2:The RF Breast coils had not been completed at the moment of submitting this first version of this document.
D2.3: MIRACLE worked on the Development of scan protocols. The coil setup and scan protocol was adequate, as from all patients spectra could be obtained. Moreover, the tumor area could be identified in 100% of the patients.
D3.1:The objective of the deliverable D3.1 is to provide the basis for the automated evaluation pipeline for the clinical application (deliverable D3.4) which is the raw data processing and evaluation pipeline harmonized across the partner sites. This will enable consistent data reconstruction and post-processing across sites, which reduces platform-specific variations, and is required for (I) a proper assessment of inter- and intra-subject variability, and (II) the accurate definition of steps for potential improvements in signal-to-noise ratio. Due to delays in the hiring process, including the training period, so far only steps 1 & 2 are being performed. The definition of a suitable data processing format and strategy, as well as implementation of necessary tools in MATLAB, are currently ongoing.
D3.2: The objective of the deliverable D3.2 is to provide optimal outcome of the metabolic pulse sequences based on the data post-processing established in deliverable D3.1. This will improve the biomarker detection. Because deliverable D3.2 requires parts of deliverable D3.1 that are still due, none of the work has been performed so far.
D4.1: WP4 addresses the primary clinical objective of MIRACLE: perform a multi-centre prospective cohort study in breast cancer patients assessing the effectiveness of MIRACLE in executing virtual biopsies and predicting the efficacy of neo- adjuvant chemotherapy. A procedure for enabling the use of non-CE labeled devices for a clinical study has been established in The Netherlands. Also the clinical study setup details have been discussed globally with all sites. Due to the Dutch governmental decision effectuated in Nov 2022, mammocare has been centralized and no longer takes place in the UMC Utrecht. This required more established results before studies can take place that effect the treatment of the patients.
Because of the more stringent requirements for proof of patient benefit, we established an independent single site study in the envisioned breast cancer population.