Clinical Trials

A first multicentric open-label non comparative randomized trial on skin cancer will be launched in 2023, in 4 leading clinical centers across Europe:

• Institut Gustave Roussy (Villejuif, France)
• Centro Hospitalar Universitário Lisboa Norte (Lisbon, Portugal)
• Universitätsklinikum Erlangen (Erlangen, Germany)
• CHUV (Lausanne, Switzerland)

The objectives are to evaluate the:

• Safety of FLASH radiotherapy on malignant cutaneous lesions and surrounding healthy tissue
• Efficacy of FLASH radiotherapy on those lesions
• Quality of life of the treated patients
• Impact on the patient journey
• Impact on the treatment cost

The expected benefits include fewer side effects on healthy tissues in comparison with conventional radiotherapy for the same delivered dose, improved patient comfort, facilitated logistics and decreased care cost.

A project was launched in 2022 to 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.

A consortium of prominent medical institutions and expert partners was created to achieve these objectives:

• 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 include:

• 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