Skip to main content
SpringerLink
Log in

Tracer Application in Cardiovascular Imaging: A Triple Jump

  • Chapter
  • First Online:
Autonomic Innervation of the Heart

Abstract

Next to aspects related to the imaging techniques, the quality of the used cardiovascular tracer is of major importance to produce reliable images, leading to accurate diagnoses as well as outcome of research and imaging-correlated treatment. We have built up this chapter on cardiovascular imaging according to the athletic triple jump. Hop, step, and jump are used as metaphors for three subsequent steps in the application of cardiovascular tracers. First, hop addresses general aspects as well as selection criteria of positron emission tomography (PET) and single-photon emission computed tomography (SPECT) tracers for cardiac innervation, myocardial perfusion, and heart failure. Second, step is focusing on the kind of translational as well as good manufacturing practice (GMP) activities needed to produce a clinical grade tracer. Third, jump, in which the relationship between clinical implementation of a radiopharmaceutical and quality management and good clinical practice (GCP) is presented.

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

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 84.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 149.00
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Abbreviations

BET:

Bacterial endotoxin tests

CAD:

Coronary artery disease

cGRPP:

Guidelines on current good radiopharmacy practice

COMT:

Catechol-O-methyltransferase

EMA:

European Medicine Agency

FDA:

Food and Drug Administration

GCP:

Good clinical practice

GDP:

Good distribution practice

GMP:

Good manufacturing practice

GRPP:

Guidelines on good radiopharmacy practice

HF:

Heart failure

IEC:

Independent ethics committee

IMP:

Investigational medicinal product

IMPD:

Investigational medicinal product dossier

MA:

Marketing authorization

MAO:

Monoamine oxidase

MPI:

Myocardial perfusion imaging

MTD:

Maximum tolerated dose

NOAEL:

No-adverse-effect level

PET:

Positron emission tomography

QA:

Quality assurance unit

QC:

Quality control

QP:

Qualified person

SOP:

Standard operating procedures

SPECT:

Single-photon emission computed tomography

SSRP:

Small-scale radiopharmaceuticals

References

  • Anagnostopoulos C, Georgakopoulos A, Pianou N, Nekolla SG (2013) Assessment of myocardial perfusion and viability by positron emission tomography. Int J Cardiol 167:1737–1749

    Article  PubMed  Google Scholar 

  • Anonymous (2007) Radiopharmacy Committee of the EANM, guidelines on current good radiopharmacy practice (cGRPP) in the preparation of radiopharmaceuticals, version 2 March 2007 URL: http://www.eanm.org/publications/guidelines/gl_radioph_cgrpp.pdf (assessed November 2014)

  • Bengel FM (2011) Imaging targets of the sympathetic nervous system of the heart: translational considerations. J Nucl Med 52:1167–1170

    Article  CAS  PubMed  Google Scholar 

  • Bengel FM, Schwaiger M (2004) Assessment of cardiac sympathetic neuronal function using PET imaging. J Nucl Cardiol 11:603–616

    Article  PubMed  Google Scholar 

  • Boersma HH, Wensing JW, Kho TL, De Brauw LM, Liem IH, Van Kroonenburgh MJ (2002) Compensatory uptake of I-123 MIBG in the contralateral adrenal gland after removal of a pheochromocytoma. Clin Nucl Med 27:113–116

    Article  PubMed  Google Scholar 

  • Candell-Riera J, Romero-Farina G, Aguade-Bruix S, Castell-Conesa J, de Leon G, Garcia-Dorado D (2009) Prognostic value of myocardial perfusion-gated SPECT in patients with ischemic cardiomyopathy. J Nucl Cardiol 16:212–221

    Article  PubMed  Google Scholar 

  • Declaration of Helsinki (2013) Website: http://www.wma.net/en/30publications/10policies/b3/index.html. (assessed March 2014)

  • Di Carli MF, Dorbala S, Meserve J, El Fakhri G, Sitek A, Moore SC (2007) Clinical myocardial perfusion PET/CT. J Nucl Med 48:783–793

    Article  PubMed  Google Scholar 

  • Elsinga P, Todde S, Penuelas I, Meyer G, Farstad B, Faivre-Chauvet A, Mikolajczak R, Westera G, Gmeiner-Stopar T, Decristoforo C (2010) Guidance on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals. Eur J Nucl Med Mol Imaging 37:1049–1062

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  • Elsinga PH, Dierckx RAJO (2014) Small molecule PET-radiopharmaceuticals. Curr Pharm Des 20:2268–2274

    Article  CAS  PubMed  Google Scholar 

  • EU-GMP-website. http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm. (assessed March 2014)

  • FDA-Guidance PET Drugs (2011) Guidance PET drugs, current good manufacturing practice (CGMP). Small entity compliance guide, FDA, Center for Drug Evaluation and Research (CDER) http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070306.pdf. (assessed November 2013)

  • GCP-website (Good clinical practices, ICH) http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html. (assessed March 2014)

  • Hillman EM, Bernus O, Pease E, Bouchard MB, Pertsov A (2014) Depth-resolved optical imaging of transmural electrical propagation in perfused heart. Opt Express 15:17827–17841

    Article  Google Scholar 

  • ICH M3-website. Non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. http://www.ich.org/products/guidelines/multidisciplinary/article/multidisciplinary-guidelines.html. (assessed November 2014)

  • Kassiou M, Mardon K, Katsifis AG, Najdovski L, Dikic B, Mattner F, Lambrecht RM, Hicks RJ, Eu P, Loc'h C (1996) Radiosynthesis of [123I]N-methyl-4-iododexetimide and [123I]N-methyl-4-iodolevetimide: in vitro and in vivo characterisation of binding to muscarinic receptors in the rat heart. Nucl Med Biol 23:147–153

    Article  CAS  PubMed  Google Scholar 

  • Langer O, Halldin C (2002) PET and SPET tracers for mapping the cardiac nervous system. Eur J Nucl Med Mol Imaging 29:416–434

    Article  CAS  PubMed  Google Scholar 

  • Mühlfeld C, Schipke J, Schmidt A, Post H, Pieske B, Sedej S (2013) Hypoinnervation is an early event in experimental myocardial remodelling induced by pressure overload. J Anat 222:634–644

    Article  PubMed  Google Scholar 

  • Paterson I, Mielniczuk LM, O'Meara E, So A, White JA (2013) Imaging heart failure: current and future applications. Can J Cardiol 29:317–328

    Article  PubMed  Google Scholar 

  • Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014. website: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0536&from=EN. (assessed November 2014)

  • Rischpler C, Park MJ, Fung GS, Javadi M, Tsui BM, Higuchi T (2012) Advances in PET myocardial perfusion imaging: F-18 labeled tracers. Ann Nucl Med 26:1–6

    Article  PubMed  Google Scholar 

  • Rollo D, Machado S, Ceschin M (2010) Design of clinical trials. Semin Nucl Med 40:332–337

    Article  PubMed  Google Scholar 

  • Tamaki N, Yoshinaga K (2011) Novel iodinated tracers, MIBG and BMIPP, for nuclear cardiology. J Nucl Cardiol 18:135–143

    Article  PubMed Central  PubMed  Google Scholar 

  • Verbruggen A, Coenen HH, Deverre JR, Guilloteau D, Langstrom B, Salvadori PA, Halldin C (2008) Guideline to regulations for radiopharmaceuticals in early phase clinical trials in the EU. Eur J Nucl Med Mol Imaging 35:2144–2151

    Article  CAS  PubMed  Google Scholar 

  • Weiland F, Chandna H, Narula J (2010) Myocardial iodine-123 meta-iodobenzylguanidine imaging and cardiac events in heart failure: results of the prospective ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) study. J Am Coll Cardiol 55:2212–2221

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, 30.001, Groningen, 9700 RB, The Netherlands

    F. Michelle de Roo, Koen Hilgerink, Jos G. W. Kosterink & Hendrikus H. Boersma PharmD, PhD

  2. Department of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, University of Groningen, 30.001, Groningen, 9700 RB, The Netherlands

    Gert Luurtsema & Hendrikus H. Boersma PharmD, PhD

  3. Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, The Netherlands

    Herman J. Woerdenbag

Authors
  1. F. Michelle de Roo
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Koen Hilgerink
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Jos G. W. Kosterink
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Gert Luurtsema
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Herman J. Woerdenbag
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Hendrikus H. Boersma PharmD, PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Hendrikus H. Boersma PharmD, PhD .

Editor information

Editors and Affiliations

  1. Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, Groningen, The Netherlands

    Riemer H.J.A. Slart

  2. Thorax center Cardiology, University Medical Center Groningen, Groningen, The Netherlands

    René A. Tio

  3. Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, Groningen, The Netherlands

    Philip H. Elsinga

  4. Nuklearmedizinische Klinik, Klinikum Rechts der Isar Technische Universität München, München, Germany

    Markus Schwaiger

Rights and permissions

Reprints and permissions

Copyright information

© 2015 Springer-Verlag Berlin Heidelberg

About this chapter

Cite this chapter

de Roo, F.M., Hilgerink, K., Kosterink, J.G.W., Luurtsema, G., Woerdenbag, H.J., Boersma, H.H. (2015). Tracer Application in Cardiovascular Imaging: A Triple Jump. In: Slart, R., Tio, R., Elsinga, P., Schwaiger, M. (eds) Autonomic Innervation of the Heart. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-45074-1_7

Download citation

  • DOI: https://doi.org/10.1007/978-3-662-45074-1_7

  • Published:

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-662-45073-4

  • Online ISBN: 978-3-662-45074-1

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation