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Risk assessment of copper-containing contraceptives: the impact for women with implanted intrauterine devices during clinical MRI and CT examinations

  • Wiebke Neumann
  • Tanja Uhrig
  • Matthias Malzacher
  • Verena Kossmann
  • Lothar R. Schad
  • Frank G. Zoellner
Magnetic Resonance

Abstract

Objectives

To assess the risks for implant users with copper-containing intrauterine devices (IUDs) during MR and CT examinations.

Methods

A tissue-mimicking phantom suitable for all experiments within this study was developed. Seven different types of copper IUDs were evaluated. Heating and dislocation of each IUD were investigated at two clinically relevant positions in 1.5 T and 3 T MR scanners. Artifacts in the field of view caused by each tested IUD were determined for clinical MR and CT imaging.

Results

No significant heating of any tested IUD was detected during MR measurements. The temperature increase was less than 0.6 K for all IUDs. Neither angular deflection nor translation of any IUD was detected. Artifacts in MR images were limited to the very vicinity of the IUDs except for one IUD containing a steel-visualizing element. Streaking artifacts in CT were severe (up to 75.5%) in the slices including the IUD.

Conclusion

No significant risk possibly harming the patient was determined during this phantom study, deeming MR examinations safe for women with an implanted copper IUD. Image quality was more impaired for CT than for MR imaging and needs careful consideration during diagnosis.

Key Points

• Risk assessment of copper-containing IUDs with regard to heating, dislocation, and artifacts during MR and CT imaging.

• Neither significant heating nor dislocation was determined in MR; image quality was more impaired for CT than for MR imaging and needs careful consideration during diagnosis.

• The tested IUDs pose no additional risks for implant users during MR and CT examinations.

Keywords

Intrauterine devices, copper Patient safety Magnetic resonance imaging Phantoms, imaging Tomography, X-ray computed 

Abbreviations

ASTM

American Society for Testing Materials

FoV

Field of view

IUD

Intrauterine device

RF

Radiofrequency

TRUFI

True fast imaging with steady-state free precession

TSE

Turbo spin echo

Notes

Acknowledgements

The authors are grateful to Marius Siegfarth (Fraunhofer PAMP) for his assistance during temperature measurements.

The IUDs used for this study were supplied by the manufacturers who had no further influence on the study.

Funding information

This research project is part of the Research Campus M2OLIE and funded by the German Federal Ministry of Education and Research (BMBF) within the Framework “Forschungscampus: public-private partnership for Innovations” under the funding code 13GW0092D.

Compliance with ethical standards

Guarantor

The scientific guarantor of this publication is Frank G. Zöllner.

Conflict of interest

The authors declare that they have no conflict of interest.

Statistics and biometry

No complex statistical methods were necessary for this paper.

Informed consent

Written informed consent was not required for this study because it was a phantom study.

Ethical approval

Institutional Review Board approval was not required because it was a phantom study.

Methodology

• Prospective

• Experimental

• Performed at one institution

References

  1. 1.
    Kavanaugh ML, Jerman J (2018) Contraceptive method use in the United States: trends and characteristics between 2008, 2012 and 2014. Contraception 97:14–21CrossRefGoogle Scholar
  2. 2.
    United Nations Population Fund (2016) TCu380A intrauterine contraceptive device (IUD) WHO/UNFPA technical specification and prequalification guidance. United Nations Population Fund, NY, USAGoogle Scholar
  3. 3.
    World Health Organization (ed) (2009) Medical eligibility criteria for contraceptive use – 4th ed. World Health Organization, GenevaGoogle Scholar
  4. 4.
    United Nations Department of Economic and Social Affairs (2011) World contraceptive use 2011. United Nations Department of Economic and Social Affairs, NY, USA. Available via http://www.un.org/esa/population/publications/contraceptive2011/wallchart_front.pdf. Accessed 01 Aug 2018
  5. 5.
    Dietrich O, Reiser MF, Schoenberg SO (2008) Artifacts in 3-T MRI: physical background and reduction strategies. Eur J Radiol 65:29–35CrossRefGoogle Scholar
  6. 6.
    Guerin B, Serano P, Iacono MI et al (2018) Realistic modeling of deep brain stimulation implants for electromagnetic MRI safety studies. Phys Med Biol 63:095015CrossRefGoogle Scholar
  7. 7.
    Golestanirad L, Angelone LM, Iacono MI, Katnani H, Wald LL, Bonmassar G (2017) Local SAR near deep brain stimulation (DBS) electrodes at 64 and 127 MHz: a simulation study of the effect of extracranial loops. Magn Reson Med 78:1558–1565CrossRefGoogle Scholar
  8. 8.
    Noureddine Y, Kraff O, Ladd ME et al (2018) In vitro and in silico assessment of RF-induced heating around intracranial aneurysm clips at 7 Tesla. Magn Reson Med 79:568–581CrossRefGoogle Scholar
  9. 9.
    Bhusal B, Bhattacharyya P, Baig T, Jones S, Martens M (2018) Measurements and simulation of RF heating of implanted stereo-electroencephalography electrodes during MR scans. Magn Reson Med.  https://doi.org/10.1002/mrm.27144 CrossRefGoogle Scholar
  10. 10.
    Winter L, Oberacker E, Özerdem C et al (2015) On the RF heating of coronary stents at 7.0 Tesla MRI. Magn Reson Med 74:999–1010CrossRefGoogle Scholar
  11. 11.
    Tse ZT, Elhawary H, Montesinos CA, Rea M, Young I, Lampérth M (2011) Testing MR image artifacts generated by engineering materials. Concepts Magn Reson 39B:109–117CrossRefGoogle Scholar
  12. 12.
    Santoro D, Winter L, Müller A et al (2012) Detailing radio frequency heating induced by coronary stents: a 7.0 Tesla magnetic resonance study. PLoS One 7:e49963CrossRefGoogle Scholar
  13. 13.
    Elhawary H, Zivanovic A, Davies B, Lamperth M (2006) A review of magnetic resonance imaging compatible manipulators in surgery. Proc Inst Mech Eng H 220:413–424CrossRefGoogle Scholar
  14. 14.
    Christoforou EG, Tsekos NV, Özcan A (2006) Design and testing of a robotic system for MR image-guided interventions. J Intell Robot Syst 47:175–196CrossRefGoogle Scholar
  15. 15.
    Tse ZT, Janssen H, Hamed A, Ristic M, Young I, Lamperth M (2009) Magnetic resonance elastography hardware design: a survey. Proc Inst Mech Eng H 223:497–514CrossRefGoogle Scholar
  16. 16.
    Barrett JF, Keat N (2004) Artifacts in CT: recognition and avoidance. Radiographics 24:1679–1691CrossRefGoogle Scholar
  17. 17.
    Lee MJ, Kim S, Lee SA et al (2007) Overcoming artifacts from metallic orthopedic implants at high-field-strength MR imaging and multi-detector CT. Radiographics 27:791–803CrossRefGoogle Scholar
  18. 18.
    Kalender WA (2011) Computer Tomography, 3rd edn. Publicis MCD Verlag, GermanyGoogle Scholar
  19. 19.
    Mark AS, Hricak H (1987) Intrauterine contraceptive devices: MR imaging. Radiology 162:311–314CrossRefGoogle Scholar
  20. 20.
    Hess T, Stepanow B, Knopp MV (1996) Safety of intrauterine contraceptive devices during MR imaging. Eur Radiol 6:66–68CrossRefGoogle Scholar
  21. 21.
    Pasquale SA, Russer TJ, Foldesy R, Mezrich RS (1997) Lack of interaction between magnetic resonance imaging and the copper-T380A IUD. Contraception 55:169–173CrossRefGoogle Scholar
  22. 22.
    Berger-Kulemann V, Einspieler H, Hachemian N et al (2013) Magnetic field interactions of copper-containing intrauterine devices in 3.0-Tesla magnetic resonance imaging: in vivo study. Korean J Radiol 14:416–422CrossRefGoogle Scholar
  23. 23.
    ASTM Standard F2119-07 (2007) Standard test method for evaluation of MR image artifacts from passive implants. ASTM International, West ConshohockenGoogle Scholar
  24. 24.
    ASTM Standard F2182-11a (2011) Standard test method measurements of radio frequency induced heating on or near passive implants during magnetic resonance imaging. ASTM International, West ConshohockenGoogle Scholar
  25. 25.
    ASTM Standard F2213-06 (2006) Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment. ASTM International, West ConshohockenGoogle Scholar
  26. 26.
    EN60601 (2017) Medical electrical equipment - Part 2–33: particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis. Beuth Verlag, BerlinGoogle Scholar
  27. 27.
    Neumann W, Lietzmann F, Schad LR, Zöllner FG (2017) Design of a multimodal (1H/23NaMR/CT) anthropomorphic thorax phantom. Z Med Phys 27:124–131Google Scholar
  28. 28.
    Kato H, Kuroda M, Yoshimura K et al (2005) Composition of MRI phantom equivalent to human tissues. Med Phys 32:3199–3208CrossRefGoogle Scholar
  29. 29.
    Schuenke P, Koehler C, Korzowski A et al (2017) Adiabatically prepared spin-lock approach for T1ρ-based dynamic glucose enhanced MRI at ultrahigh fields. Magn Reson Med 78:215–225CrossRefGoogle Scholar
  30. 30.
    Nordbeck P, Fidler F, Weiss I et al (2008) Spatial distribution of RF-induced E-fields and implant heating in MRI. Magn Reson Med 60:312–319CrossRefGoogle Scholar
  31. 31.
    Optocon AG (2012). Reference manual for fiber optic thermometer FOTEMP1-4. Available via http://www.optocon.de/en/products/fiber-optic-temperature-signal-conditioners/fotemp1-4-fiber-optic-single-channel-thermometer/. Accessed 01 Aug 2018
  32. 32.
    Shellock FG (2002) Biomedical implants and devices: assessment of magnetic field interactions with a 3.0-Tesla MR system. J Magn Reson Imaging 16(6):721–732CrossRefGoogle Scholar
  33. 33.
    van der Schaaf I, van Leeuwen M, Vlassenbroek A, Velthuis B (2006) Minimizing clip artifacts in multi CT angiography of clipped patients. AJNR Am J Neuroradiol 27:60–66PubMedGoogle Scholar
  34. 34.
    Ulaby FT, Michielssen E, Ravaioli U (2015) Fundamentals of applied electromagnetics, global edition. Pearson Education Limited, EssexGoogle Scholar
  35. 35.
    Yeung CJ, Susil RC, Atalar E (2002) RF safety of wires in interventional MRI: using a safety index. Magn Reson Med 47:187–193CrossRefGoogle Scholar
  36. 36.
    Samoudi AM, Vermeeren G, Tanghe E, Van Holen R, Martens L, Josephs W (2016) Numerically simulated exposure of children and adults to pulsed gradient fields in MRI. J Magn Reson Imaging 44:1360–1367CrossRefGoogle Scholar

Copyright information

© European Society of Radiology 2018

Authors and Affiliations

  1. 1.Computer Assisted Clinical Medicine, Medical Faculty MannheimHeidelberg UniversityMannheimGermany

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