Use of diffusion-weighted MR images okayedFebruary 5, 2020
Elekta has received 510(k) premarket notification from the US FDA for the use of diffusion-weighted MR images (DWI).
This expands the clinical utility of Elekta Unity to include biologic assessment of tumour response during therapy, allowing treatment adaptation based not just on gross anatomic changes but also on early biologic changes at the cellular level.
Elekta Unity, the world’s first high-field MR-Linac, received initial 510(k) clearance in December 2018 and CE mark in June 2018.
DWI creates a map of the diffusion of water molecules at the cellular level and can be processed to generate the apparent diffusion coefficient, or ADC. A growing body of evidence shows that ADC changes within a tumour can provide important insights into an individual’s tumour response that would previously have been unavailable during radiation treatment.
Elekta Unity combines a state-of-the-art 1.5T MRI scanner and a best-in-class 7MV linear accelerator, giving it the ability to reshape the radiation dose based on daily changes in shape, size and position of tumour and surrounding healthy anatomy, the company said.