Use of MR-contrast agents outside of their labeled indication

Purpose. The use of MRI contrast agents outside their labeled indications i s routine in radiology. However, physicians feel frequently at unease. It i s the aim of this paper to introduce the medical, juridicial and billing re levant 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 eve n the medical state of the art. Conclusion. The necessity for off-label use will continue to increase for M R-contrast agents, as clinical trials for registration purpose are quite co stly and manufactures continuously will concentrate on the essential indica tions.