FDA Clears Automated Dosimetry with the Monte Carlo Method for Radionuclide Therapy

While calculations with previous use of Monte Carlo dosimetry could take hours, the Food and Drug Administration (FDA) has granted 510(k) clearance for a dose planning method that facilitates automated use of this dosimetry technique in seconds for radiotherapy applications.

Clinicians will now be able to access automated Monte Carlo dosimetry with the dose planning method through the MIM SurePlan MRT platform (MIM Software/GE HealthCare). While GE HealthCare said the Monte Carlo method has been acknowledged as a gold standard in dosimetry for radiophamaceutical therapy, clinicians can now review absorbed doses with this technique in a few clicks.

“It is exciting that the dose planning method code developed and validated at our institution will be available to the theranostics community at large with the recent FDA clearance,” said Yuni Dewaraja, PhD, a professor of radiology at the University of Michigan. “This opens up the possibility for harmonized and accurate patient-specific dosimetry across centers, which can lead to robust dose-effect relationships, dosimetry-guided radiopharmaceutical therapy, and ultimately a greater benefit for patients receiving these promising therapies.”

GE HealthCare added that the MIM SurePlan MRT automates dosimetry processes such as organ-at-risk segmentation, time-activity curve fitting and single photon emission computed tomography (SPECT) reconstruction.