Skip to main content

Advertisement

SpringerLink
Log in

Non-inferiority of a non-gadolinium-enhanced magnetic resonance imaging follow-up protocol for isolated optic pathway gliomas

  • Original Article
  • Published:
Pediatric Radiology Aims and scope Submit manuscript

Abstract

Background

Pediatric patients with optic pathway gliomas (OPGs) typically undergo a large number of follow-up MRI brain exams with gadolinium-based contrast media (GBCM), which have been associated with gadolinium tissue retention. Therefore, careful consideration of GBCM use in these children is warranted.

Objective

To investigate whether GBCM is necessary for OPG MR imaging response assessment using a blinded, non-inferiority, multi-reader study.

Materials and methods

We identified children with OPG and either stable disease or change in tumor size on MRI using a regional cancer registry serving the U.S. Pacific Northwest. For each child, the two relevant, consecutive MRI studies were anonymized and standardized into two imaging sets excluding or including GBCM-enhanced images. Exam pairs were compiled from 42 children with isolated OPG (19 with neurofibromatosis type 1), from a population of 106 children with OPG. We included 28 exam pairs in which there was a change in size between exams. Seven pediatric radiologists measured tumor sizes during three blinded sessions, spaced by at least 1 week. The first measuring session excluded GBCM-enhanced sequences; the others did not. The primary endpoint was intra-reader agreement for ≥ 25% change in axial cross-product measurement, using a 12% non-inferiority threshold.

Results

Analysis demonstrated an overall 1.2% difference (95% confidence interval, –3.2% to 5.5%) for intra-reader agreement using a non-GBCM-enhanced protocol and background variability.

Conclusion

A non-GBCM-enhanced protocol was non-inferior to a GBCM-enhanced protocol for assessing change in size of isolated OPGs on follow-up MRI exams.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

References

  1. Kanda T, Fukusato T, Matsuda M et al (2015) Gadolinium-based contrast agent accumulates in the brain even in subjects without severe renal dysfunction: evaluation of autopsy brain specimens with inductively coupled plasma mass spectroscopy. Radiology 276:228–232

    Article  Google Scholar 

  2. Miller JH, Hu HH, Pokorney A et al (2015) MRI brain signal intensity changes of a child during the course of 35 gadolinium contrast examinations. Pediatrics 136:e1637–1640

  3. Mithal LB, Patel PS, Mithal D et al (2017) Use of gadolnium-based magnetic resonance imaging contrast agents and awareness of brain gadolinium deposition among pediatric providers in North America. Pediatr Radiol 47:657–664

    Article  Google Scholar 

  4. Roberts DR, Chatterjee AR, Yazdani M et al (2016) Pediatric patients demonstrate progressive T1-weighted hyperintensity in the dentate nucleus following multiple doses of gadolinium-based contrast agent. AJNR Am J Neuroradiol 37:2340–2347

    Article  CAS  Google Scholar 

  5. McDonald JS, McDonald RJ, Jentoft ME et al (2017) Intracranial gadolinium deposition following gadodiamide-enhanced magnetic resonance imaging in pediatric patients: a case-control study. JAMA Pediatr 171:705–707

    Article  Google Scholar 

  6. Stanescu AL, Shaw DW, Murata N et al (2020) Brain tissue gadolinium retention in pediatric patients after contrast-enhanced magnetic resonance exams: pathological confirmation. Pediatr Radiol 50:388–396

    Article  Google Scholar 

  7. Murata N, Murata K, Gonzalez-Cuyar LF, Maravilla KR (2016) Gadolinium tissue deposition in brain and bone. Magn Reson Imaging 34:1359–1365

    Article  CAS  Google Scholar 

  8. Roberts DR, Lindhorst SM, Welsh CT et al (2016) High levels of gadolinium deposition in the skin of a patient with normal renal function. Invest Radiol 51:280–289

    Article  CAS  Google Scholar 

  9. Maximova N, Gregori M, Zennaro F et al (2016) Hepatic gadolinium deposition and reversibility after contrast agent-enhanced MR imaging of pediatric hematopoietic stem cell transplant recipients. Radiology 281:418–426

    Article  Google Scholar 

  10. United States Food and Drug Administration (2017) FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings. https://www.fda.gov/media/109825/download. Accessed 11 May 2020

  11. American College of Radiology (2021) ACR manual on contrast media 2020. https://www.acr.org/-/media/ACR/Files/Clinical-Resources/Contrast_Media.pdf. Accessed 11 May 2020

  12. Harrington SG, Jaimes C, Weagle KM et al (2021) Strategies to perform magnetic resonance imaging in infants and young children without sedation. Pediatr Radiol. https://doi.org/10.1007/s00247-021-05062-3

    Article  PubMed  PubMed Central  Google Scholar 

  13. Heideman RL (1993) Tumors of the central nervous system. In: Pizzo PA, Poplack DG (eds) Principles and practice of pediatric oncology. JB Lippincott, Philadelphia, pp 633–681

    Google Scholar 

  14. Albers AC, Gutmann DH (2009) Gliomas in patients with neurofibromatosis type 1. Expert Rev Neurother 9:535–539

    Article  Google Scholar 

  15. Wan MJ, Ullrich NJ, Manley PE et al (2016) Long-term visual outcomes of optic pathway gliomas in pediatric patients without neurofibromatosis type 1. J Neurooncol 129:173–178

    Article  Google Scholar 

  16. Fisher MJ, Loguidice M, Gutmann DH et al (2012) Visual outcomes in children with neurofibromatosis type 1 — associated optic pathway glioma following chemotherapy: a multicenter retrospective analysis. Neuro Oncol 14:790–797

    Article  Google Scholar 

  17. Maloney E, Stanescu AL, Perez FA et al (2018) Surveillance magnetic resonance imaging for isolated optic pathway gliomas: is gadolinium necessary? Pediatr Radiol 48:1472–1484

    Article  Google Scholar 

  18. Campion T, Quirk B, Cooper J et al (2020) Surveillance imaging of grade 1 astrocytomas in children: can duration and frequency of follow-up imaging and the use of contrast agents be reduced? Neuroradiology 63:953–958

    Article  Google Scholar 

  19. Marsault P, Ducassou S, Menut F et al (2019) Diagnostic performance of an unenhanced MRI exam for tumor follow-up of the optic pathway gliomas in children. Neuroradiology 61:711–720

    Article  Google Scholar 

  20. Hernaiz Driever P, von Hornstein S, Pietsch T et al (2010) Natural history and management of low-grade glioma in NF-1 children. J Neurooncol 100:199–207

    Article  Google Scholar 

  21. Kornreich L, Blaser S, Schwarz M et al (2001) Optic pathway glioma: correlation of imaging findings with the presence of neurofibromatosis. AJNR Am J Neuroradiol 22:1963–1969

    CAS  PubMed  PubMed Central  Google Scholar 

  22. Kerrison JB (2005) Chapter 38: phacomatoses. In: Miller NR (ed) Walsh & Hoyt’s clinical neuro-ophthalmology, 6th edn. Lippincott Williams & Wilkins, Philadelphia, pp 1823–1898

    Google Scholar 

  23. Chateil JF, Soussotte C, Pedespan JM et al (2001) MRI and clinical differences between optic pathway tumours in children with and without neurofibromatosis. Br J Radiol 74:24–31

    Article  CAS  Google Scholar 

  24. Taylor T, Jaspan T, Milano G et al (2008) Radiological classification of optic pathway gliomas: experience of a modified functional classification system. Br J Radiol 81:761–766

    Article  CAS  Google Scholar 

  25. Obuchowski NA (2009) Reducing the number of reader interpretations in MRMC studies. Acad Radiol 16:209–217

    Article  Google Scholar 

  26. Ater JL, Zhou T, Holmes E et al (2012) Randomized study of two chemotherapy regimens for treatment of low-grade glioma in young children: a report from the Children’s Oncology Group. J Clin Oncol 30:2641–2647

    Article  Google Scholar 

  27. Kelly JP, Leary S, Khanna P, Weiss AH (2012) Longitudinal measures of visual function, tumor volume, and prediction of visual outcomes after treatment of optic pathway gliomas. Ophthalmology 119:1231–1237

    Article  Google Scholar 

  28. Shofty B, Mauda-Havakuk M, Weizman L et al (2015) The effect of chemotherapy on optic pathway gliomas and their sub-components: a volumetric MR analysis study. Pediatr Blood Cancer 62:1353–1359

    Article  CAS  Google Scholar 

  29. van den Bent MJ, Wefel JS, Schiff D et al (2011) Response assessment in neuro-oncology (a report of the RANO group): assessment of outcome in trials of diffuse low-grade gliomas. Lancet Oncol 12:583–593

    Article  Google Scholar 

  30. Wen PY, Chang SM, Van den Bent MJ et al (2017) Response assessment in neuro-oncology clinical trials. J Clin Oncol 35:2439–2449

    Article  CAS  Google Scholar 

  31. Fangusaro J, Witt O, Hernaiz Driever P et al (2020) Response assessment in paediatric low-grade glioma: recommendations from the Response Assessment in Pediatric Neuro-Oncology (RAPNO) working group. Lancet Oncol 21:e305–e316

    Article  Google Scholar 

  32. Prasad SR, Jhaveri KS, Saini S et al (2002) CT tumor measurement for therapeutic response assessment: comparison of unidimensional, bidimensional, and volumetric techniques initial observations. Radiology 225:416–419

    Article  Google Scholar 

  33. Sohaib SA, Turner B, Hanson JA et al (2000) CT assessment of tumour response to treatment: comparison of linear, cross-sectional and volumetric measures of tumour size. Br J Radiol 73:1178–1184

    Article  CAS  Google Scholar 

  34. R Core Team (2016). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna. https://www.R-project.org/. Accessed 25 Sep 2021

  35. McHugh ML (2012) Interrater reliability: the kappa statistic. Biochem Med 22:276–282

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Radiology, Seattle Children’s Hospital, 4800 Sand Point Way NE, Seattle, WA, 98105, USA

    Ezekiel Maloney, Francisco A. Perez, Ramesh S. Iyer, Randolph K. Otto, Jason N. Wright, Sarah J. Menashe, Dennis W. W. Shaw & A. Luana Stanescu

  2. Department of Radiology, University of Washington, Seattle, WA, USA

    Ezekiel Maloney, Francisco A. Perez, Ramesh S. Iyer, Randolph K. Otto, Jason N. Wright, Sarah J. Menashe, Dennis W. W. Shaw & A. Luana Stanescu

  3. Clinical Biostatistics, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, 98109, WA, USA

    Daniel S. Hippe

Authors
  1. Ezekiel Maloney
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Francisco A. Perez
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Ramesh S. Iyer
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Randolph K. Otto
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Jason N. Wright
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Sarah J. Menashe
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Daniel S. Hippe
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Dennis W. W. Shaw
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. A. Luana Stanescu
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Ezekiel Maloney.

Ethics declarations

Conflicts of interest

None

Additional information

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Maloney, E., Perez, F.A., Iyer, R.S. et al. Non-inferiority of a non-gadolinium-enhanced magnetic resonance imaging follow-up protocol for isolated optic pathway gliomas. Pediatr Radiol 52, 539–548 (2022). https://doi.org/10.1007/s00247-021-05226-1

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00247-021-05226-1

Keywords

Search

Navigation