References

1.     Medicine I of. Emerging Safety Science: Workshop Summary. 2008. https://doi.org/10.17226/11975.

2.     US Food & Drug Administration. List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). FDA 2020. https://www.fda.gov/medical-devices/vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-vitro-and-imaging-tools (accessed July 21, 2020).

3.     Del Vecchio S, Zannetti A, Fonti R, Pace L, Salvatore M. Nuclear imaging in cancer theranostics. Q J Nucl Med Mol Imaging 2007;51:152–63.

4.     Smanik PA, Liu Q, Furminger TL, Ryu K, Xing S, Mazzaferri EL, et al. Cloning of the human sodium lodide symporter. Biochem Biophys Res Commun 1996;226:339–45. https://doi.org/10.1006/bbrc.1996.1358.

5.     Robbins RJ, Schlumberger MJ. The evolving role of (131)I for the treatment of differentiated thyroid carcinoma. J Nucl Med 2005;46 Suppl 1:28S-37S.

6.     Wyszomirska A. Iodine-131 for therapy of thyroid diseases. Physical and biological basis. Nucl Med Rev Cent East Eur 2012;15:120–3.

7.     Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, et al. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumours. New England Journal of Medicine 2017;376:125–35. https://doi.org/10.1056/NEJMoa1607427.

8.     Rahbar K, Bodei L, Morris MJ. Is the Vision of Radioligand Therapy for Prostate Cancer Becoming a Reality? An Overview of the Phase III VISION Trial and Its Importance for the Future of Theranostics. J Nucl Med 2019;60:1504–6. https://doi.org/10.2967/jnumed.119.234054.

9.     Eberlein U, Cremonesi M, Lassmann M. Individualized Dosimetry for Theranostics: Necessary, Nice to Have, or Counterproductive? J Nucl Med 2017;58:97S-103S. https://doi.org/10.2967/jnumed.116.186841.

10.     Garin E, Rolland Y, Pracht M, Le Sourd S, Laffont S, Mesbah H, et al. High impact of macroaggregated albumin-based tumour dose on response and overall survival in hepatocellular carcinoma patients treated with 90 Y-loaded glass microsphere radioembolization. Liver Int 2017;37:101–10. https://doi.org/10.1111/liv.13220.

11.     Hermann A-L, Dieudonné A, Ronot M, Sanchez M, Pereira H, Chatellier G, et al. Relationship of Tumour Radiation–absorbed Dose to Survival and Response in Hepatocellular Carcinoma Treated with Transarterial Radioembolization with 90Y in the SARAH Study. Radiology 2020:191606. https://doi.org/10.1148/radiol.2020191606.

12.     Imhof A, Brunner P, Marincek N, Briel M, Schindler C, Rasch H, et al. Response, Survival, and Long-Term Toxicity After Therapy With the Radiolabelled  Somatostatin Analogue ue [90 Y-DOTA]-TOC in Metastasized Neuroendocrine Cancers. Journal of Clinical Oncology 2011;29:2416–2423. https://doi.org/10.1200/JCO.2010.33.7873.

13.     Suman S, Parghane RV, Joshi A, Prabhash K, Bakshi G, Talole S, et al. Therapeutic efficacy, prognostic variables and clinical outcome of 177Lu-PSMA-617 PRLT in progressive mCRPC following multiple lines of treatment: prognostic implications of high FDG uptake on dual tracer PET-CT vis-à-vis Gleason score in such cohort. Br J Radiol 2019;92:20190380. https://doi.org/10.1259/bjr.20190380.

14.     Garon EB, Rizvi NA, Hui R, Leighl N, Balmanoukian AS, Eder JP, et al. Pembrolizumab for the Treatment of Non–Small-Cell Lung Cancer. New England Journal of Medicine 2015;372:2018–28. https://doi.org/10.1056/NEJMoa1501824.

15.     Zhang J, Shi Z, Xu X, Yu Z, Mi J. The influence of microenvironment on tumour immunotherapy. The FEBS Journal 2019;286:4160–75. https://doi.org/10.1111/febs.15028.

16.     Van Overmeire E, Laoui D, Keirsse J, Van Ginderachter JA. Hypoxia and tumour-associated macrophages: A deadly alliance in support of tumour progression. Oncoimmunology 2014;3:e27561. https://doi.org/10.4161/onci.27561.

17.     Niemeijer AN, Leung D, Huisman MC, Bahce I, Hoekstra OS, van Dongen GAMS, et al. Whole body PD-1 and PD-L1 positron emission tomography in patients with non-small-cell lung cancer. Nature Communications 2018;9:4664. https://doi.org/10.1038/s41467-018-07131-y.

18.     Bensch F, van der Veen EL, Lub-de Hooge MN, Jorritsma-Smit A, Boellaard R, Kok IC, et al. 89Zr-atezolizumab imaging as a non-invasive approach to assess clinical response to PD-L1 blockade in cancer. Nat Med 2018;24:1852–8. https://doi.org/10.1038/s41591-018-0255-8.

19.     Tang H, Qiao J, Fu Y-X. Immunotherapy and tumour microenvironment. Cancer Lett 2016;370:85–90. https://doi.org/10.1016/j.canlet.2015.10.009.

20.     Sykiotis GP, Kalliolias GD, Papavassiliou AG. Pharmacogenetic principles in the Hippocratic writings. J Clin Pharmacol 2005;45:1218–20. https://doi.org/10.1177/0091270005281091.

21.     EUR-Lex - 32013L0059 - EN - EUR-Lex n.d. https://eur-lex.europa.eu/eli/dir/2013/59/oj (accessed July 21, 2020).

22.     Sjögreen Gleisner K, Spezi E, Solny P, Gabina PM, Cicone F, Stokke C, et al. Variations in the practice of molecular radiotherapy and implementation of dosimetry: results from a European survey. EJNMMI Phys 2017;4:28. https://doi.org/10.1186/s40658-017-0193-4.

23.     Stokke C, Gabiña PM, Solný P, Cicone F, Sandström M, Gleisner KS, et al. Dosimetry-based treatment planning for molecular radiotherapy: a summary of the 2017 report from the Internal Dosimetry Task Force. EJNMMI Phys 2017;4:27. https://doi.org/10.1186/s40658-017-0194-3.

24.     Chiesa C, Pacilio M, Strigari L, Bagni O, Goretti OSM, Maccauro M, et al. TERAPIA MEDICO NUCLEARE: OTTIMIZZAZIONE SU BASE DOSIMETRICA AI SENSI DELLA DIRETTIVA EUROPEA 2013/59/EURATOM n.d.:40.

25.     Sjögreen-Gleisner K, Flux G, Bacher K, Chiesa C, de Nijs R, Kagadis GC, Lima T, Georgosopoulou ML, Gabiña PM, Nekolla S, Peters S, Santos J, Sattler B, Stokke C, Tran-Gia J, Gilligan P, Bardiès M. EFOMP policy statement NO. 19: Dosimetry in nuclear medicine therapy - Molecular radiotherapy. Phys Med. 2023 Dec;116:103166. doi: 10.1016/j.ejmp.2023.103166. Epub 2023 Nov 4. PMID: 3792664

26.     Chiesa C, Sjogreen Gleisner K, Flux G, Gear J, Walrand S, Bacher K, et al. The conflict between treatment optimization and registration of radiopharmaceuticals with fixed activity posology in oncological nuclear medicine therapy. Eur J Nucl Med Mol Imaging 2017;44:1783–6. https://doi.org/10.1007/s00259-017-3707-3.

27.     European Medicines Agency. Concept paper on clinical evaluation of therapeutic radiopharmaceuticals in oncology [Internet]. Committee for Medicinal Products for Human Use (CHMP); 2024 Oct. Report No.: EMA/CHMP/451705/2024. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-clinical-evaluation-therapeutic-radiopharmaceuticals-oncology_en.pdf

28.     Caruana CJ, Tsapaki V, Damilakis J, Brambilla M, Martín GM, Dimov A, et al. EFOMP policy statement 16: The role and competences of medical physicists and medical physics experts under 2013/59/EURATOM. Phys Med 2018;48:162–8. https://doi.org/10.1016/j.ejmp.2018.03.001.

29.     Strigari L, Konijnenberg M, Chiesa C, Bardies M, Du Y, Gleisner KS, et al. The evidence base for the use of internal dosimetry in the clinical practice of molecular radiotherapy. Eur J Nucl Med Mol Imaging 2014;41:1976–88. https://doi.org/10.1007/s00259-014-2824-5.

30.     Sgouros G, Bolch WE, Chiti A, et al. ICRU REPORT 96, Dosimetry-Guided Radiopharmaceutical Therapy. Journal of the ICRU. 2022;21(1):1-212. doi:10.1177/14736691211060117

31.     Lassmann M, Chiesa C, Flux G, Bardiès M, EANM Dosimetry Committee. EANM Dosimetry Committee guidance document: good practice of clinical dosimetry reporting. Eur J Nucl Med Mol Imaging 2011;38:192–200. https://doi.org/10.1007/s00259-010-1549-3.

32.     Siegel JA, Thomas SR, Stubbs JB, Stabin MG, Hays MT, Koral KF, et al. MIRD pamphlet no. 16: Techniques for quantitative radiopharmaceutical biodistribution data acquisition and analysis for use in human radiation dose estimates. J Nucl Med 1999;40:37S-61S.

33.     Wessels BW, Konijnenberg MW, Dale RG, Breitz HB, Cremonesi M, Meredith RF, et al. MIRD Pamphlet No. 20: The Effect of Model Assumptions on Kidney Dosimetry and Response–Implications for Radionuclide Therapy. Journal of Nuclear Medicine 2008;49:1884–1899. https://doi.org/10.2967/jnumed.108.053173.

34.     Bolch WE, Eckerman KF, Sgouros G, Thomas SR. MIRD pamphlet No. 21: a generalized schema for radiopharmaceutical dosimetry--standardization of nomenclature. J Nucl Med 2009;50:477–84. https://doi.org/10.2967/jnumed.108.056036.

35.     Sgouros G, Roeske JC, McDevitt MR, Palm S, Allen BJ, Fisher DR, et al. MIRD Pamphlet No. 22 (Abridged): Radiobiology and Dosimetry of α-Particle Emitters for Targeted Radionuclide Therapy. J Nucl Med 2010;51:311–28. https://doi.org/10.2967/jnumed.108.058651.

36.     Dewaraja YK, Frey EC, Sgouros G, Brill AB, Roberson P, Zanzonico PB, et al. MIRD pamphlet No. 23: quantitative SPECT for patient-specific 3-dimensional dosimetry in internal radionuclide therapy. J Nucl Med 2012;53:1310–25. https://doi.org/10.2967/jnumed.111.100123.

37.     Dewaraja YK, Ljungberg M, Green AJ, Zanzonico PB, Frey EC, SNMMI MIRD Committee SM, et al. MIRD pamphlet No. 24: Guidelines for quantitative 131I SPECT in dosimetry applications. Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine 2013;54:2182–8. https://doi.org/10.2967/jnumed.113.122390.

38.     Ljungberg M, Celler A, Konijnenberg MW, Eckerman KF, Dewaraja YK, Sjogreen-Gleisner K, et al. MIRD Pamphlet No. 26: Joint EANM/MIRD Guidelines for Quantitative 177Lu SPECT Applied for Dosimetry of Radiopharmaceutical Therapy. Journal of Nuclear Medicine 2016;57:151–162. https://doi.org/10.2967/jnumed.115.159012.

39.     Gear J, Chiesa C, Lassmann M, Gabiña PM, Tran-Gia J, Stokke C, et al. EANM Dosimetry Committee series on standard operational procedures for internal dosimetry for 131I mIBG treatment of neuroendocrine tumours. EJNMMI Phys 2020;7:15. https://doi.org/10.1186/s40658-020-0282-7.

40.     Hänscheid H, Canzi C, Eschner W, Flux G, Luster M, Strigari L, et al. EANM Dosimetry Committee Series on Standard Operational Procedures for Pre-Therapeutic Dosimetry II. Dosimetry prior to radioiodine therapy of benign thyroid diseases n.d.

41.     Hindorf C, Glatting G, Chiesa C, Lindén O, Flux G. EANM Dosimetry Committee guidelines for bone marrow and whole-body dosimetry. Eur J Nucl Med Mol Imaging 2010;37:1238–50. https://doi.org/10.1007/s00259-010-1422-4.

42.     Lassmann M, Hänscheid H, Chiesa C, Hindorf C, Flux G, Luster M. EANM Dosimetry Committee series on standard operational procedures for pre-therapeutic dosimetry I: blood and bone marrow dosimetry in differentiated thyroid cancer therapy 2008. https://doi.org/10.1007/s00259-008-0761-x.

43.     Gear JI, Cox MG, Gustafsson J, Gleisner KS, Murray I, Glatting G, et al. EANM practical guidance on uncertainty analysis for molecular radiotherapy absorbed dose calculations. Eur J Nucl Med Mol Imaging 2018;45:2456–74. https://doi.org/10.1007/s00259-018-4136-7.

44.     Huq MS, Fraass BA, Dunscombe PB, Gibbons JP, Ibbott GS, Mundt AJ, et al. The report of Task Group 100 of the AAPM: Application of risk analysis methods to radiation therapy quality management. Med Phys 2016;43:4209. https://doi.org/10.1118/1.4947547.