A patient being treated for liver cancer was scheduled to be administered two SIR-spheres treatments (SIR-spheres utilizes radioactive micro-spheres that contain
yttrium-90). The first treatment was prescribed as 0.46 GBq (GigaBecquerels) of
Y-90. Due to difficulty in determining how much of the
Y-90 remained in the vial and the injection catheter, the licensee has determined that only 0.25 GBq were administered in the first treatment dose. The patient will be given a second treatment that takes into consideration the actual amount administered on the first treatment.
The licensee notes that the fraction of Y-90 administered differs from the prescribed dose by 46%. The regulatory criteria under 10 CFR
35.3045(a)(1)(iii) states that the reportability criteria is 50% or greater. The licensee has elected to conservatively report this event since it is close to the regulatory criteria.