A comparison of four radionuclide dose calibrators using various radionuclides and measurement geometries clinically used in nuclear medicine

Bauwens, Matthias; Pooters, Ivo; Cobben, Rianda; Visser, M. G. W.; Schnerr, R. S.; Mottaghy, Felix M.; Wildberger, Joachim E.; Wierts, Roel

doi:10.1016/j.ejmp.2019.03.012

Cited by 12 publications

(10 citation statements)

References 15 publications

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“…For 111 In, 123 I and 124 I measurement deviations frequently exceeded the ± 5% and often even the ± 10% limits. This is in agreement with values reported in literature for 111 In and 123 I [9,10,15]. To the best of our knowledge, no multi-center data are available on the typical accuracy of 124 I clinical activity measurements.…”

Section: Discussionsupporting

confidence: 92%

“…Recent studies [9][10][11] demonstrated large measurement deviations ( > ± 10%) for several individual diagnostic radionuclides commonly used (particularly for 111 In and 68 Ga). However, no large multi-center studies have reported on the impact of radionuclide calibrator accuracy on activity measurements in the increasing application of personalized molecular radiotherapy based on a theranostic approach.…”

Section: Introductionmentioning

confidence: 99%

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An international multi-center investigation on the accuracy of radionuclide calibrators in nuclear medicine theranostics

Vargas

Bauwens

Pooters

et al. 2020

Preprint

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Background: Personalized molecular radiotherapy based on theranostics requires accurate quantification of the amount of radiopharmaceutical activity administered to patients both in diagnostic and therapeutic applications. This international multi-center study aims to investigate the clinical measurement accuracy of radionuclide calibrators for 7 radionuclides used in theranostics: 99mTc, 111In, 123I, 124I, 131I, 177Lu and 90Y.Methods: In total, 32 radionuclide calibrators from 8 hospitals located in the Netherlands, Belgium and Germany were tested. For each radionuclide, a set of four samples comprising two clinical containers (10-mL glass vial and 3-mL syringe) with two filling volumes were measured. The reference value of each sample was determined by two certified radioactivity calibration centers (SCK CEN and JRC) using two secondary standard ionization chambers. The deviation in measured activity with respect to the reference value was determined for each radionuclide and each measurement geometry. In addition, the combined systematic deviation of activity measurements in a theranostic setting was evaluated for 5 clinically-relevant theranostic pairs: 131I/123I, 131I/124I, 177Lu/111In, 90Y/99mTc and 90Y/111In.Results: For 99mTc, 131I, and 177Lu, a small minority of measurements were not within ±5% range from the reference activity (percentage of measurements not within range: 99mTc: 6%, 131I: 14%, 177Lu: 24%) and almost none were outside ±10% range. However, for 111In, 123I, 124I and 90Y more than half of all measurements were not accurate within ±5% range (111In: 51%, 123I: 83%, 124I: 63%, 90Y: 61%) and not all were within ±10% margin (111In: 22%, 123I: 35%, 124I: 15%, 90Y: 25%). A large variability in measurement accuracy was observed between radionuclide calibrator systems, type of sample container (vial vs syringe), and source-geometry calibration/correction settings used. Consequently, we observed large combined deviations (percentage deviation > ±10%) for the investigated theranostic pairs, in particular for 90Y/111In, 131I/123I and 90Y/99mTc.Conclusions: Our study shows that substantial over- or under-estimation of therapeutic patient doses are likely to occur in a theranostic setting due to errors in the assessment of radioactivity with radionuclide calibrators. These findings underline the importance of thorough validation of radionuclide calibrator systems for each clinically-relevant radionuclide and sample geometry.

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Section: Discussionsupporting

confidence: 92%

Section: Introductionmentioning

confidence: 99%

An international multi-center investigation on the accuracy of radionuclide calibrators in nuclear medicine theranostics

Vargas

Bauwens

Pooters

et al. 2020

Preprint

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“…In a recent study, accuracy of four different types of radionuclide calibrators was investigated for 68 Ga by using well-calibrated gamma spectrometry. The results were surprising in that all the radionuclide calibrator systems showed a systematic error in the range of 10-25% [76,146]. It was reported that the deviations were mainly due to the incorrect factory-shipped dose calibrator setting.…”

Section: Production For the Clinical Applicationsmentioning

confidence: 98%

“…Geometry effects (same reading for the same amount of activity irrespective of the volume or the vial of the sample) can dramatically affect the activity measurements, particularly for low-energy X-ray or gamma photons. It should be, therefore, assessed for the vials used to collect the product, as well as those used for quality control and in GMP [76,77].…”

Section: Quality Control Of the Radionuclide For Preclinical Studiesmentioning

confidence: 99%

A Step-by-Step Guide for the Novel Radiometal Production for Medical Applications: Case Studies with 68Ga, 44Sc, 177Lu and 161Tb

et al. 2020

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The production of novel radionuclides is the first step towards the development of new effective radiopharmaceuticals, and the quality thereof directly affects the preclinical and clinical phases. In this review, novel radiometal production for medical applications is briefly elucidated. The production status of the imaging nuclide 44Sc and the therapeutic β--emitter nuclide 161Tb are compared to their more established counterparts, 68Ga and 177Lu according to their targetry, irradiation process, radiochemistry, and quality control aspects. The detailed discussion of these significant issues will help towards the future introduction of these promising radionuclides into drug manufacture for clinical application under Good Manufacturing Practice (GMP).

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“…However, previous studies have reported deviations in CC for isotopes other than 18 F [29]. These deviations were attributed to incorrect calibration factors within the dose calibrators [30] or effects resulting from the use of different isotope containers between calibration and clinical routine [31]. To account for these issues, a check of the CC for all PET isotopes in clinical use is recommended to be done at least once.…”

Section: Target Gain Valuementioning

confidence: 99%

Clinically Valuable Quality Control for PET/MRI Systems: Consensus Recommendation From the HYBRID Consortium

et al. 2019

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A comparison of four radionuclide dose calibrators using various radionuclides and measurement geometries clinically used in nuclear medicine

Cited by 12 publications

References 15 publications

An international multi-center investigation on the accuracy of radionuclide calibrators in nuclear medicine theranostics

An international multi-center investigation on the accuracy of radionuclide calibrators in nuclear medicine theranostics

A Step-by-Step Guide for the Novel Radiometal Production for Medical Applications: Case Studies with 68Ga, 44Sc, 177Lu and 161Tb

Clinically Valuable Quality Control for PET/MRI Systems: Consensus Recommendation From the HYBRID Consortium

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