[Administration of MR contrast agents outside of approved indications (off-label use].
OBJECTIVE
The use of MRI contrast agents outside their labeled indications is routine in radiology. However, physicians feel frequently at unease. It is the aim of this paper to introduce the medical, juridicial and billing relevant issues in order to improve the knowledge on this topic.


METHODS
The basis for off-label use is the physician's prerogative, which finds its basis in the "declaration of Helsinki".


RESULTS
Off-label use is allowed under special conditions and might be even the medical state of the art.


CONCLUSIONS
The necessity for off-label use will continue to increase for MR-contrast agents, as clinical trials for registration purpose are quite costly and manufactures continuously will concentrate on the essential indications.
Knopp
M V
MV
Forschungsschwerpunkt Radiologische Diagnostik und Therapie, Deutsches Krebsforschungszentrum (dkfz), Im Neuenheimer Feld 280, 69120 Heidelberg. M.Knopp@dkfz.de
Lodemann
M
M
Kage
U
U
Runge
V M
VM
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D003287:Contrast Media / Q000008:administration & dosage* / Q000009:adverse effects; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005858:Germany; D006801:Humans; D007089:Image Enhancement; D008279:Magnetic Resonance Imaging; D008318:Malpractice / Q000331:legislation & jurisprudence
D003287:Contrast Media