IBA treats first patient in C-FLASH-01, its first clinical trial as sponsor

Feasibility study in re-irradiation for head and neck cancer

C-FLASH-01 (NCT07644585) is presented as the first feasibility study in humans dedicated to ConformalFLASH proton therapy. It is conducted under an Investigational Device Exemption (IDE) authorization granted by the FDA.

The trial evaluates the feasibility of treating patients requiring re-irradiation for head and neck cancer using fractionated ConformalFLASH proton therapy, utilizing proton beams delivered at the Bragg peak. It concerns patients requiring re-irradiation for head and neck cancer who cannot benefit from surgical resection.

ConformalFLASH®, IBA's Proton FLASH irradiation solution, is currently in the research and development phase. It aims to combine the physical precision of proton therapy with ultra-high dose rate administration capabilities. According to the statement, the potential clinical benefits of this approach remain under study.

An ecosystem of technical partners at the service of innovation

Olivier Legrain, Chief Executive Officer of IBA, stated: "With C-FLASH-01, IBA is not merely providing the technology that makes this innovation possible: the company is also actively supporting its clinical evaluation as part of this trial, of which it is the sponsor."

Several companies are participating in the initiative. RaySearch Laboratories provides a research version of its FLASH treatment planning system, and 3D Systems handles 3D printing of patient-specific devices, including the ConformalFLASH Energy Modulator (CEM).

.decimal supplies custom collimators machined with precision, while IBA Dosimetry develops dosimetry solutions compatible with FLASH technology, including FLASH Lynx and MatriXX Air. For IBA, data from the study could help guide future development of ConformalFLASH and its potential integration into proton therapy clinical workflows.