SIR-Spheres activity measurements reveal systematic miscalibration

Abstract

Purpose: Accurate dosimetry-guided radiopharmaceutical therapy fundamentally relies on knowledge of the quantity of radioactivity administered to patients. The purpose of this work was to perform an independent and NIST-traceable activity measurement of 90Y SIR-Spheres®.

Methods: Gamma spectroscopic measurements of the 90Y internal pair production decay mode were made using a high-purity germanium detector. Un-modified patient SIR-Spheres® vials were placed within a high-density polyethylene source holder positioned at a distance of 210 cm from the detector, with acquisition durations of 3 – 6 hours. Measured annihilation radiation detection rates were corrected for radioactive decay during acquisition, dead time, source attenuation, and source geometry effects. Detection efficiency was determined by two independent and NIST-traceable methods. Resulting 90Y activity measurements were compared against the manufacturer activity calibration.

Results: Measured SIR-Sphere® vials (n = 5) were found to contain more activity than specified by the manufacturer calibration – on average the ratio of measured activity to calibrated was 1.233 ± 0.030. Activity measurements made using two distinct efficiency calibration methods were found to agree within 1%. Uncertainty in individual measurements was dominated by counting statistical uncertainty (~2.5%), uncertainty in the internal pair production branching ratio of 90Y (1.5%), and efficiency calibration (1.2% – 1.9%).

Conclusion: The primary SIR-Spheres® activity calibration appears to be a significant underestimate of true activity. This mis-calibration has likely been consistent for as long as the SIR-Sphere® product has been available. This finding should be independently verified, and steps should be taken by the manufacturer to establish an accurate and traceable activity standard.

Publication
In Journal of Nuclear Medicine