MIRACLE · Project

MRI-Based Test That Predicts If Breast Cancer Chemotherapy Will Work Before Treatment Starts

healthPrototypeTRL 4Thin data (2/5)

Right now, doctors basically have to start chemotherapy and wait to see if it shrinks the tumor — putting patients through harsh side effects with no guarantee it will work. This project found a way to peek inside breast tissue using a powerful MRI scanner and read the chemical signatures of cell membranes. By measuring the ratio of certain fats being built up versus broken down, they can predict with 96% accuracy whether chemo will actually work — up from the current 75%. Think of it like checking the oil in your car engine before deciding on a repair strategy, instead of just replacing parts and hoping for the best.

By the numbers

96%

Prediction accuracy for chemotherapy response using phospholipid biomarker

75%

Current prediction accuracy without the biomarker

Subjects planned for validation study at dual MRI field strengths

Clinical MRI field strength where biomarker imaging was demonstrated

10.5T

World's most powerful MRI used for validation comparison

EUR 100,000

Total EU contribution

Consortium partners across 2 countries (NL, US)

The business problem

What needed solving

Oncologists today start chemotherapy for breast cancer patients without reliably knowing if it will work — current prediction methods are only 75% accurate. This means roughly 1 in 4 patients endures the severe side effects of chemotherapy that ultimately fails to treat their cancer. A non-invasive way to predict treatment response before starting chemo would save patients from unnecessary suffering and save healthcare systems from wasted treatment costs.

The solution

What was built

The project delivered a phantom demo of pulse sequence implementation for detecting phospholipid biomarkers via 7T MRI. It also established the validation study design comparing biomarker detection at 7T and 10.5T MRI across 10 subjects, and formed a spin-out company (Wavetronica) to provide specialized RF hardware for high-field MRI systems.

Audience

Who needs this

MRI scanner manufacturers seeking precision oncology features (Siemens Healthineers, Philips Healthcare, GE HealthCare)RF coil and antenna companies building accessories for 7T MRI systemsUniversity hospitals and cancer centers with high-field MRI installationsCompanion diagnostics companies developing biomarker-based treatment selection testsPharmaceutical companies running breast cancer clinical trials needing better response prediction

Business applications

Who can put this to work

Medical imaging equipment

enterprise

Target: MRI scanner manufacturers and RF coil/antenna developers

If you are an MRI hardware company looking for the next clinical differentiator — this project developed specialized RF antenna technology and pulse sequences for 7T MRI that can image phospholipid biomarkers non-invasively. The validation showed prediction accuracy jumping from 75% to 96%. A spin-out company was already formed to provide the 7T and 10.5T specific hardware, signaling a clear commercialization path.

Oncology diagnostics

mid-size

Target: Clinical diagnostics companies and companion diagnostics developers

If you are a diagnostics company seeking new biomarker-based tests for cancer treatment selection — this project validated a phospholipid biomarker (PE/GPC ratio) that predicts chemotherapy response in breast cancer with 96% accuracy. The team discussed fast-track FDA clearance at a joint ISMRM-Eusobi meeting. With 10 subjects validated across two MRI field strengths, this could become a companion diagnostic for oncologists.

Hospital radiology

enterprise

Target: University hospitals and cancer centers with 7T MRI installations

If you run a radiology department with high-field MRI and want to offer precision oncology services — this project proved that 7T MRI can image the chemical markers that predict chemo response non-invasively. The pulse sequence implementation was demonstrated on phantoms. Adding this capability could attract referrals from oncology departments and differentiate your center in breast cancer care.

Frequently asked

Quick answers

What would it cost to implement this imaging capability?

The project operated on a EUR 100,000 budget as a Coordination and Support Action, focused on validation study design rather than full product development. Implementing the technology requires access to a 7T MRI system and specialized RF hardware from the spin-out company formed during the project. Based on available project data, specific pricing for the hardware components is not disclosed.

Can this scale to standard hospital MRI systems?

The biomarker detection was demonstrated at 7T clinical MRI field strength, which is increasingly available at major medical centers. The validation study compared results at 7T and 10.5T to assess accuracy. Based on available project data, scaling to lower-field systems (1.5T or 3T) was not part of the scope.

What is the IP and licensing situation?

A spin-out company (Wavetronica) was formed specifically to provide the 7T and 10.5T specific hardware, suggesting IP is being commercialized. The project builds on the earlier NICI project (FET-OPEN, grant 801075). Licensing arrangements would need to be discussed with UMC Utrecht and the spin-out company.

What regulatory approvals are needed?

The team discussed fast-track FDA clearance at the joint ISMRM-Eusobi meeting in Las Vegas 2018. The validation study with 10 subjects at two field strengths was designed to support this regulatory pathway. Based on available project data, FDA clearance has not yet been achieved.

How does the 96% accuracy compare to current methods?

According to the project objective, current methods predict chemotherapy response with 75% accuracy. The phospholipid biomarker (PE/GPC ratio) increased this to 96% accuracy. This was demonstrated using multi-nuclear MRI to image the build-up and breakdown products of cell membranes.

What is the timeline to clinical availability?

The project ran from 2019 to 2021 and is now closed. A phantom demo was completed, and a 10-subject validation study was planned across 7T and 10.5T systems. Based on available project data, further clinical trials and FDA clearance would be needed before routine clinical use.

Consortium

Who built it

This is a lean, focused consortium of 3 partners across the Netherlands and the United States. UMC Utrecht leads the project and brings clinical MRI expertise at 7T. The University of Minnesota provides access to patients and the world's strongest MRI at 10.5T. One industry partner (an SME spin-out) was formed specifically to commercialize the RF hardware, giving the consortium a 33% industry ratio. The small EUR 100,000 budget reflects its nature as a Coordination and Support Action — this was about validating the concept and planning the commercialization path rather than full-scale product development. The transatlantic setup connecting European clinical leadership with American infrastructure is notable for regulatory strategy targeting FDA clearance.

UNIVERSITAIR MEDISCH CENTRUM UTRECHTCoordinator · NL
REGENTS OF UNIVERSITY OF MINNESOTAparticipant · US

How to reach the team

Coordinator is at UMC Utrecht (Netherlands). The spin-out company Wavetronica may be the commercial contact point.

Order a report on this consortium See UNIVERSITAIR MEDISCH CENTRUM UTRECHT profile →

Next steps

Talk to the team behind this work.

Want to explore licensing the biomarker imaging technology or integrating the RF hardware into your MRI platform? SciTransfer can connect you with the right people at UMC Utrecht and Wavetronica.

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