GE HealthCare MIM Software Nets FDA Clearance of Monte Carlo Dosimetry for Theranostics

GE HealthCare’s MIM Software announced 510(k) clearance from the FDA to perform absorbed dose calculation of radionuclides using a Monte Carlo method. With this clearance, Monte Carlo dosimetry via the Dose Planning Method (DPM) will be available for use with MIM SurePlan MRT, MIM So ware’s comprehensive solution for automating and standardizing dosimetry in Theranostics.

Theranostics represents a more personalized form a medicine – one which treats each patient as an individual, recognizing that the same treatment plan and dose doesn’t work for everyone, all with the goal of providing more effective medical care. As such, its practicerelies on advanced molecular imaging, targeted therapies, and accurate dosimetry working together to provide a personalized and precise approach to medical diagnosis and treatment.

Specifically, the purpose of dosimetry in radiotherapy is to estimate the amount of dose that will be absorbed by normal tissues and tumors to anticipate the biologic effects of radiation. As Theranostics and the use of radiopharmaceutical therapy (RPT) to treat cancer and other diseases have become more prevalent, interest in using dosimetry to personalize RPT treatments has grown.

Today, the Monte Carlo method is considered a “gold standard” for RPT dosimetry and has been shown to achieve high calculation accuracy in tissues of heterogeneous densities, including lungs. Likewise, DPM is an industry-recognized Monte Carlo technique developed by the University of Michigan that enables simulation of photons and electrons.

“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, Professor, Radiology, 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.”

Traditionally, the Monte Carlo technique has been considered too slow for clinical use, taking up to several hours or more to complete calculations. MIM SurePlan MRT with the Dose Planning Method can provide fast and accurate Monte Carlo dose calculations within seconds via a central processing unit in healthcare organizations’ existing hardware – a graphics processing unit is not required.

MIM SurePlan MRT turns an otherwise cumbersome process of performing dosimetry into a clinically realistic process via automation and standardization. In just a few clicks, and with built-in guidance, users are able to review absorbed doses. Steps such as SPECT reconstruction, organ-at-risk segmentation, and time-activity curve fitting can be automated.

“Enabling wide access to precise, personalized treatment options for cancer is a key part of our mission,” said Andrew Nelson, CEO of MIM Software, GE HealthCare. “With the addition of Monte Carlo dosimetry for radiopharmaceutical therapy, we are excited to offer healthcare organizations fast, accurate absorbed dose calculation without needing to acquire additional computer hardware. We hope this will ultimately increase the number of patients who have access to personalized Theranostics.”