MIRACLE – An accessible and affordable virtual biopsy tool that can identify cancer biomarkers and tumor activity without shedding a drop of patient blood

An add-on device for  7T MRI scanners that determines the efficacy of chemotherapy in breast cancer patients.

Within the EU-funded MIRACLE project an add-on device for  7T MRI scanners is developed that determines the efficacy of chemotherapy in breast cancer patients after one to two round of chemotherapy. In current practice patients receive six rounds of chemotherapy before efficacy can determined based on tumor size. In over 30% of patients tumors do not shrink meaning that chemo is ineffective, and the chemotherapy is stopped, and other treatments might be started. The MIRACLE coil determines efficacy sooner based on biomarkers. This leads to an improved Quality of Life in patients, it enables caregivers to change to other treatment strategies faster, and reduces health care costs.

The MIRACLE project develops an add-on device for magnetic resonance imaging (MRI) scanners to enable virtual biopsies, providing information on tumour margins for improving surgery and metabolic information for more effective therapies. This accurate and rapid non-invasive procedure will provide doctors with the information needed to create personalised treatment plans for given patients’ and tumour characteristics. The project partners’ previous research led to the development of an MRI coil for the non-invasive detection of metabolic biomarkers. The new project objective is to develop breast coil hardware and software, using breast cancer as a case study for evaluation.

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-a-Service 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, as demonstrated in FET- OPEN-01-2016-2017-801075 – the Non-Invasive-Chemistry-Imaging (NICI) and FET-OPEN-03-2018-2019-2020 – FET Innovation Launchpad – MIRACLE. 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 supported by the Dutch reimbursement company VGZ, Tesla DC, and oncologists showing there is a strong market demand. Now the challenge lies in bringing the breast coil PoC hardware and software to the next level using breast cancer as a use case.

The problem

Breast cancer accounts for 13.3% of all new cancer cases diagnosed in EU-27 countries in 2020

The problem:

  • Breast cancer patients do not benefit from the best treatment strategies tailored to their cancer due to inaccurate preoperative tumor characterization.
  • These patients are susceptible to overtreatment and systemic therapy increases the Symptom Burden (SB) and decreases the Quality of Life (QOL).
  • In advanced breast cancer, the efficacy of clinical chemotherapy standards can be down to 30%

In the figure above, copied from The Cancer Atlas, is clearly stated that worldwide breast cancer is the most frequently diagnosed cancer in women, 2018 in all pink countries. (source)

The Pre-operative field is in need of change. MIRACLE offers a solution: A fully non-invasive preoperative characterization method based on high-field strength (7T) phosphorus signal detection

MIRACLE’s Unique Selling Points

  • A fully non-invasive virtual biopsy approach capable of effectively predicting neo-adjuvant chemotherapy efficacy

  • A plug-and-play RF coil and software solution adaptable to Philips, Siemens and GE MRI systems

  • A use case in breast cancer that is expandable to various types of solid cancer

MIRACLE’s IMPACT

  • Improving quality of life and Reduce Symptom Burden by preventing unnecessary chemotherapy treatment.

  • Decrease scanning time  from 15-120 min to 15-30 min.

  • Reduce unnecessary chemotherapy from over 30% to 4%.

  • Reduce Health care cost with approximately €6.000 per patient. With over 18.000 new diagnoses each year this could save over 35M euros.

A MIRACLE presentation

Partners

The Faces

The MIRACLE Team of WaveTronica at the office location in Geldermalsen

MIRALE Meeting at ISMRM 2024 Singapore with large part of the consortium.

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