Vision, Mission & Objectives

Achieve the translation of FLASH radiation therapy to clinical use and provide cost-effective treatments to patients as well as improve the radiotherapy patient journey.

Objectives of the Consortium

• Offer patients a therapeutic alternative for cancer treatment, with less side effects
• Make FLASHKNiFE CE-marked and commercially available at the end of the EIT Health project from 2025
• Ensure broad adoption and large access to FLASHKNiFE across Europe and beyond

Expected impacts:

• For patients: Improving comfort, quality of life, and personal life by giving a more efficient treatment in a single radiotherapy session, with less to no side effects
• For society: Providing a cost-effective solution while optimizing logistical resources
• For clinicians: Introducing a new and better way of treating multi-resistant tumors
• For research: Disseminating new knowledge in the fields of FLASH radiation therapy and radiation oncology

Project Overview

The FLASHKNiFE Consortium aims to overcome the limitations of conventional radiotherapy by using FLASH or very high doses of radiation to reduce toxicity on healthy tissue while keeping the same destructive effect on tumors.

At the beginning of the project, four identical FLASHKNiFE units are developed and manufactured. They are then clinically validated thanks to a two years clinical trial in four clinical centers. During this clinical trial, patients with skin cancer are recruited. Simultaneously, market access and commercialization strategies are built and implemented. Comprehensive communication will ensure knowledge dissemination. The objective is to ensure rapid adoption of FLASHKNiFE after obtaining the CE mark under the new EU MDR regulation 2017/745.

The FLASHKNiFE Consortium has a total budget of 8.2 M € and is co-funded by EIT Health (2.5 M €) and its partners. The project duration is three years.

FLASH Radiotherapy: a Game-Changing Therapy

FLASH radiation therapy delivers an ultra-high radiation dose (≥100Gy/second, compared to a few Gy/minute in conventional radiotherapy) within an ultra-short treatment time (typically 0.1 second in a single session). Preliminary experiments with FLASH-radiotherapy were found to increase the differential effect between tumors and normal tissues, i.e. it has the same destructive effect on the tumor as conventional radiotherapy, while sparing normal tissue. 

FLASHKNiFE

FLASHKNiFE is an electron FLASH radiation therapy system, equipped with:

• An electron LINAC (up to 10 MeV) capable of delivering average dose rates up to 350 Gy/s (vs. 0.1 Gy/s in the case of conventional radiotherapy), for a tissue penetration depth up to 3 cm
• An interactive robot (or cobot) for improved ergonomics, controlled remotely to position the device, then manually controlled for fine robot-assisted positioning and alignment of the electron applicator over the treated area
• A mobile base, controlled remotely for easy transportation inside a room, a hospital of a medical center

Clinical trial

The clinical trial to evaluate the safety and efficacy of FLASHKNiFE is performed at four clinical centers (3 partners of the Consortium and 1 associated partner):

• Institut Gustave Roussy (France); Principal investigator: Prof Eric Deutsch
• Universitätsklinikum Erlangen (Germany); Investigator : Prof Rainer Fietkau
• Centro Hospitalar Universitário Lisboa Norte (Portugal); Investigator: Prof Maria Filomena de Pina
• CHUV, Lausanne University Hospital (Switzerland); Investigator: Prof Jean Bourhis

For this randomized trial, a total number of 150 patients with skin cancer will be recruited on two arms.