On 22 September 2016, 19 years after its initial approval on 22 July 1997 for dedicated MRI of the liver, MultiHance from Bracco Imaging received approval within Europe for use in MRI of all body areas, in adult and paediatric patients.
The 'whole-body' approval for MultiHance from Bracco Imaging represents the culmination of a series of indication-specific approvals received in the intervening years (see figure, above) and highlights the multipurpose value of MultiHance across all MRI applications. The whole-body indication covers the following applications:
Compared with other approved MR contrast agents, MultiHance has two unique properties that offer advantages for MRI applications. Firstly, MultiHance has a dual-imaging capability that combines the properties of a conventional extra-cellular fluid (ECF) contrast agent with those of an agent targeted specifically to the liver. Thus, MultiHance can be used for dynamic and delayed hepatobiliary phase imaging of the liver in a manner similar to that of a dedicated hepatobiliary contrast agent.
Secondly, MultiHance has markedly higher r1 relaxivity than conventional ECF agents, meaning that greater signal intensity (SI) enhancement is achievable for an equivalent administered dose. This increased SI enhancement permits significantly more diagnostic information to be obtained with MultiHance than would otherwise be obtained with standard-relaxivity GBCAs.
The additional applications included in the whole-body approval add to the versatility of MultiHance and increase the possibilities for improved imaging performance. Data on the diagnostic performance of MultiHance for some of the newer approved indications, including the results of several meta-analyses, are included in the updated Summary of Product Characteristics (SPC ). These meta-analyses have demonstrated pooled sensitivity and specificity values of 94.7 and 95.5%, respectively, for the detection of pancreatic cancer, and 83.6 and 88.0%, respectively, for the detection of prostate cancer lesions.
For cardiac MRI, the administration of two 0.05mmol/kg of doses of MultiHance during rest and stress imaging provided sensitivity and specificity values ranging from 81.0 to 94.9, and 75.0 and 100%, respectively, for detection of ischaemic areas/perfusion defects or reduced coronary flow reserve, while a dose of 0.1mmol/kg MultiHance provided 95.0% accuracy for the characterisation of cardiac neoplasms. The data is similarly provided for applications in other areas including kidney and urinary tract, adrenal glands, gastrointestinal tract, and head and neck.
With its approval for MRI of all body areas, MultiHance now offers radiological departments the opportunity for just 'one product on the shelf'.
MultiHance Summary of Product Characteristics is available at the link below; other references available upon request.