Summary: GE HealthCare’s MIM Software has received FDA clearance to use the Monte Carlo method for dosimetry in its SurePlan MRT, providing faster, accurate dose calculations to support personalized radiopharmaceutical therapy.
Key Takeaways
- GE HealthCare’s MIM Software received FDA clearance to use the Monte Carlo method for dosimetry in its SurePlan MRT, enhancing personalized treatment in Theranostics.
- The Dose Planning Method (DPM) enables fast, accurate Monte Carlo dose calculations in seconds, streamlining dosimetry with existing hardware.
- This FDA clearance supports the use of MIM SurePlan MRT as a vendor-neutral dosimetry solution across multiple healthcare facilities, expanding access to precise radiopharmaceutical therapy.
———————————————————————————————————————————————————————
GE HealthCare’s MIM Software has received 510(k) clearance from the U.S. FDA to use the Monte Carlo method for absorbed dose calculation of radionuclides. This clearance allows Monte Carlo dosimetry via the Dose Planning Method (DPM) to be used in MIM SurePlan MRT, a tool that automates and standardizes dosimetry in Theranostics.
Inside the Monte Carlo Method
Theranostics focuses on individualized treatment, requiring accurate dosimetry to estimate radiation doses absorbed by both healthy tissues and tumors. With the growing use of radiopharmaceutical therapy (RPT), interest in personalized dosimetry has increased.
The Monte Carlo method is recognized as the standard for RPT dosimetry due to its accuracy in tissues with varying densities. The DPM, developed at the University of Michigan, is a known Monte Carlo technique.
“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,” says Yuni Dewaraja, PhD, radiology professor at the University of Michigan. “This opens up the possibility for harmonized and accurate patient-specific dosimetry across centers, leading to more effective radiopharmaceutical therapy.”
Hardware-Free Dosimetry
Traditionally, the Monte Carlo technique has been slow, taking hours for dose calculations. MIM SurePlan MRT with DPM now enables fast Monte Carlo dose calculations in seconds using existing hardware without requiring a graphics processing unit. MIM SurePlan MRT streamlines dosimetry through automation, standardizing steps like SPECT reconstruction, organ-at-risk segmentation, and time-activity curve fitting.
“Enabling wide access to precise, personalized treatment options for cancer is a key part of our mission,” says Andrew Nelson, CEO of MIM Software. “With Monte Carlo dosimetry, we can provide fast, accurate dose calculations without additional hardware, potentially expanding access to personalized Theranostics.”
This addition further supports MIM SurePlan MRT as a vendor-neutral dosimetry solution used by RPT Comprehensive Centers of Excellence and healthcare facilities in 23 countries.