- AI
- Molecular Imaging
- CT
- X-Ray
- Ultrasound
- MRI
- Facility Management
- Mammography
FDA Clears Automated Dosimetry with the Monte Carlo Method for Radionuclide Therapy
The clearance may facilitate improved standardization and efficiency of dosimetry-guided, theranostic applications of radiopharmaceutical 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.
The availability of a dose planning method through the MIM SurePlan MRT platform may allow clinicians access to automated dosimetry assessment with the Monte Carlo method in seconds, according to GE HealthCare, the manufacturer of the MIM SurePlan MRT platform. (Photo courtesy of GE HealthCare.)
“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.
Radiology ‘Game-Changer’: FDA Approves PET Agent for Enhanced Detection of Coronary Artery Disease
September 28th 2024Offering higher diagnostic efficacy than SPECT imaging for coronary artery disease (CAD) detection, the PET myocardial perfusion imaging agent Flyrcado™ (flurpiridaz F 18, GE HealthCare) provides unit dose availability and effectiveness in imaging patients with high BMI.
Study for Emerging PET/CT Agent Reveals ‘New Standard’ for Detecting Clear Cell Renal Cell Carcinoma
September 11th 2024Results from a multicenter phase 3 trial showed that the PET/CT imaging agent (89Zr)Zr-girentuximab had an 85.5 percent mean sensitivity rate for the diagnosis of clear cell renal cell carcinoma.
Researchers Show Higher Breast Cancer Upstaging Rate with 18F-FAPI PET/CT
September 9th 2024The imaging agent 18F-FAPI PET/CT demonstrated greater than a 45 percent higher sensitivity rate in comparison to 18F-FDG PET/CT for the detection of axillary and extraaxillary regional lymph node metastases, according to a lesion-based analysis from a recent study.
Emerging PET Imaging Agent Gets FDA’s Breakthrough Therapy Designation for Cardiac Amyloidosis
August 5th 2024Reportedly the only imaging agent to garner a breakthrough therapy designation for cardiac amyloidosis, 124I-evuzamitide has demonstrated robust sensitivity for the condition as well as a favorable safety profile.
