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.
Keywords
- Positron Emission Tomography
- Myocardial Perfusion Imaging
- Good Manufacture Practice
- Qualified Person
- Independent Ethic Committee
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.
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- 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
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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
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