SOLLID - a single centre study to develop methods to investigate the effects of low radiation doses within nuclear medicine, to enable multicentre epidemiological investigations

Glenn Flux, Iain Murray, Dominic Rushforth, Paul Gape, Carla Abreu, Martin Lee, Ana Ribeiro, Rebecca Gregory, Sarah Chittenden, Jim Thurston, Yong Du, Jonathan Gear, Glenn Flux, Iain Murray, Dominic Rushforth, Paul Gape, Carla Abreu, Martin Lee, Ana Ribeiro, Rebecca Gregory, Sarah Chittenden, Jim Thurston, Yong Du, Jonathan Gear

Abstract

There is continuing debate concerning the risks of secondary malignancies from low levels of radiation exposure. The current model used for radiation protection is predicated on the assumption that even very low levels of exposure may entail risk. This has profound implications for medical procedures involving ionising radiation as radiation doses must be carefully monitored, and for diagnostic procedures are minimised as far as possible. This incurs considerable expense. The SOLLID study (ClinicalTrials.gov Identifier: NCT03580161) aims to develop the methodology to enable a large-scale epidemiological investigation of the effect of radiopharmaceutical administrations to patients undergoing diagnostic nuclear medicine procedures. Patients will undergo a series of scans in addition to that acquired as standard of care to enable the radiation doses delivered to healthy organs to be accurately calculated. Detailed analysis will be performed to determine the uncertainty in the radiation dose calculations as a function of the number and type of scans acquired. It is intended that this will inform a subsequent long-term multicentre epidemiological study that would address the question definitively. Secondary aims of the study are to evaluate the range of absorbed doses that are delivered from diagnostic nuclear medicine procedures and to use current risk models to ascertain the relative risks from these administrations.

References

    1. Ross JC, Vilić D, Fongenie B. Reforming the debate around radiation risk. J Radiol Prot 2019; 39: 635–40. doi: 10.1088/1361-6498/ab1698
    1. Weber W, Zanzonico P. The controversial linear No-Threshold model. J Nucl Med 2017; 58: 7–8. doi: 10.2967/jnumed.116.182667
    1. ICRP publication 105. radiation protection in medicine. Ann ICRP 2007; 37: 1–63. doi: 10.1016/j.icrp.2008.08.001
    1. Shore RE, Beck HL, Boice JD, Caffrey EA, Davis S, Grogan HA, et al. . Recent epidemiologic studies and the linear No-Threshold model for radiation Protection-Considerations regarding NCRP commentary 27. Health Phys 2019; 116: 235–46. doi: 10.1097/HP.0000000000001015
    1. NHS NHS England Imaging and Radiodiagnostic activity. 2014. Available from: .
    1. ICRP Radiation dose to patients from radiopharmaceuticals. ICRP publication 53 Ann ICRP 1988; 18(1-4).
    1. ICRP. Radiation dose to patients from radiopharmaceuticals Addendum 3 to ICRP publication 53. ICRP publication 106.. . Ann ICRP 2008; 38(1-2): 1–197Approved by the Commission in October 2007.
    1. 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. doi: 10.1007/s00259-014-2824-5
    1. Eberlein U, Bröer JH, Vandevoorde C, Santos P, Bardiès M, Bacher K, et al. . Biokinetics and dosimetry of commonly used radiopharmaceuticals in diagnostic nuclear medicine - a review. Eur J Nucl Med Mol Imaging 2011; 38: 2269–81. doi: 10.1007/s00259-011-1904-z
    1. Quinn B, Dauer Z, Pandit-Taskar N, Schoder H, Dauer LT. Radiation dosimetry of 18F-FDG PET/CT: incorporating exam-specific parameters in dose estimates. BMC Med Imaging 2016; 16: 41. doi: 10.1186/s12880-016-0143-y
    1. Pfob CH, Ziegler S, Graner FP, Köhner M, Schachoff S, Blechert B, et al. . Biodistribution and radiation dosimetry of (68)Ga-PSMA HBED CC-a PSMA specific probe for PET imaging of prostate cancer. Eur J Nucl Med Mol Imaging 2016; 43: 1962–70. doi: 10.1007/s00259-016-3424-3
    1. Gregory RA, Murray I, Gear J, Leek F, Chittenden S, Fenwick A, et al. . Standardised quantitative radioiodine SPECT/CT imaging for multicentre dosimetry trials in molecular radiotherapy. Phys Med Biol 2019; 64: 245013. doi: 10.1088/1361-6560/ab5b6c
    1. Stabin MG, Sparks RB, Crowe E. OLINDA/EXM: the second-generation personal computer software for internal dose assessment in nuclear medicine. J Nucl Med 2005; 46: 1023–7.
    1. Andersson M, Johansson L, Eckerman K, Mattsson S. IDAC-Dose 2.1, an internal dosimetry program for diagnostic nuclear medicine based on the ICRP adult reference voxel phantoms. EJNMMI Res 2017; 7: 88. doi: 10.1186/s13550-017-0339-3
    1. Divoli A, Chiavassa S, Ferrer L, Barbet J, Flux GD, Bardiès M. Effect of patient morphology on dosimetric calculations for internal irradiation as assessed by comparisons of Monte Carlo versus conventional methodologies. J Nucl Med 2009; 50: 316–23. doi: 10.2967/jnumed.108.056705
    1. Spielmann V, Li WB, Zankl M, Oeh U, Hoeschen C. Uncertainty quantification in internal dose calculations for seven selected radiopharmaceuticals. J Nucl Med 2016; 57: 122–8. doi: 10.2967/jnumed.115.160713
    1. 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. doi: 10.1007/s00259-018-4136-7
    1. Ribeiro AS, Lee M, Oyen WJG. EANM commitment towards involvement and engagement of patients and the public: learning from the UK experience. Eur J Nucl Med Mol Imaging 2019; 46: 2218–9. doi: 10.1007/s00259-019-04457-7
    1. INVOLVE INVOLVE: briefing notes for researchers: public involvement in NHS, public health and social care research.. Available from: .
    1. The Ionising Radiation (Medical Exposure) Regulations. 2017Regulation 12 (7) b [Available from. Available from: .
    1. European Council directive 2013/59/Euratom on basic safety standards for protection against the dangers arising from exposure to ionising radiation. OJ of the EU 2014;. : : 1–73Chapter 2, Article 4 (13)L13; 57.
    1. Little MP, Wakeford R, Tawn EJ, Bouffler SD, Berrington de Gonzalez A. Risks associated with low doses and low dose rates of ionizing radiation: why linearity may be (almost) the best we can do. Radiology 2009; 251: 6–12. doi: 10.1148/radiol.2511081686
    1. Siegel JA, Pennington CW, Sacks B. Subjecting radiologic imaging to the linear No-Threshold hypothesis: a non Sequitur of Non-Trivial proportion. J Nucl Med 2017; 58: 1–6. doi: 10.2967/jnumed.116.180182
    1. Wadsley J, Gregory R, Flux G, Newbold K, Du Y, Moss L, et al. . SELIMETRY-a multicentre I-131 dosimetry trial: a clinical perspective. Br J Radiol 2017; 90: 20160637. doi: 10.1259/bjr.20160637
    1. Taprogge J, Leek F, Flux GD. Physics aspects of setting up a multicenter clinical trial involving internal dosimetry of radioiodine treatment of differentiated thyroid cancer. Q J Nucl Med Mol Imaging 2019; 63: 271–7. doi: 10.23736/S1824-4785.19.03202-3
    1. Brown SR, Hall A, Buckley HL, Flanagan L, Gonzalez de Castro D, Farnell K, et al. . Investigating the potential clinical benefit of selumetinib in resensitising advanced iodine refractory differentiated thyroid cancer to radioiodine therapy (SEL-I-METRY): protocol for a multicentre UK single arm phase II trial. BMC Cancer 2019; 19: 582. doi: 10.1186/s12885-019-5541-4
    1. Grande S, Palma A, Cisbani E, De Angelis C, Della Monaca S, Dini V, et al. . MEDIRAD project "implications of medical low-dose radiation exposure": Enhancing the protection of patients and health professionals from exposure to low-dose medical radiation. Nuovo Cim C-Colloq C 2018; 41.

Source: PubMed

3
Abonner