RT Journal Article SR Electronic T1 Radiation dosimetry of Tc99m-PSMA I&S: a single-center prospective study JF Journal of Nuclear Medicine JO J Nucl Med FD Society of Nuclear Medicine SP jnumed.120.253476 DO 10.2967/jnumed.120.253476 A1 Urbán, Szabolcs A1 Meyer, Catherine A1 Dahlbom, Magnus A1 Farkas, István A1 Sipka, Gábor A1 Besenyi, Zsuzsanna A1 Czernin, Johannes A1 Calais, Jeremie A1 Pávics, László YR 2020 UL http://jnm.snmjournals.org/content/early/2020/12/04/jnumed.120.253476.abstract AB Introduction: Tc-99m-labeled Mas3-y-nal-k(Sub-KuE) (Tc-99m-PSMA I&S) is a prostate specific membrane antigen (PSMA) tracer that can be used for planar and SPECT/CT gamma imaging and radio-guided surgery (RGS). The primary aim of this study was to estimate the dosimetry of Tc-99m-PSMA I&S using a hybrid method (sequential gamma planar imaging and one single SPECT/CT) in healthy volunteers. The secondary aim was to depict the tracer biodistribution and tumor-to-background ratios (TBR) in patients with prostate cancer (PCa). Methods: Dosimetry of Tc-99m-PSMA I&S was investigated in four healthy volunteers. Whole-body planar imaging was acquired at 1, 2, 3, 6 and 24 hours, and SPECT/CT at 6h after tracer injection. Contours of organs were drawn on all acquisitions to determine organ activity at each timepoint. Absorbed dose was estimated using two Methods: 1) independent curve-fitting manual method (Levenberg-Marquardt-based algorithm using dose factors from Radiation Dose Assessment Resource (RADAR) web site) and 2) OLINDA/EXM® v 2.0 software (HERMES Medical Solutions). Biodistribution of Tc-99m-PSMA I&S was assessed in ten patients with PCa on SPECT/CT images at 6 h. Tumor uptake (SUVmax), and TBR (tumor SUVmax/ background organ SUVmean) using muscle (T/M), bladder (T/B) and intestine (T/I) as background organs were determined. Results: The mean injected activity of Tc-99m-PSMA I&S was 717 MBq (range: 562-828). No adverse events related to the injection of Tc-99m-PSMA-I&S were reported. The average radiation effective dose was 0.0055 mSv/MBq with the RADAR manual method and 0.0052 mSv/MBq with OLINDA/EXM®. Total body effective dose ranged between 3.33-4.42 and 3.11-4.23 mSv, respectively. All PCa patients showed high tracer uptake in primary and metastatic lesions with T/M, T/B, T/I ranging from 5.29 - 110, 0.11 – 7.02 and 0.96 – 16.30, respectively. Conclusion: Effective doses of Tc-99m-PSMA I&S were comparable to those known for most of the Tc-99m tracers and was lower than 68Ga-labelled and 18F-labelled agents. Tc-99m-PSMA I&S SPECT/CT showed high TBR in PCa patients. This study can provide required data for translation and approval of Tc-99m-PSMA I&S by regulatory agencies.