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MnDPDP for MR imaging of the liver. Results from the European phase III studies
C G Torres1, B Lundby, A T Sterud
1Nycomed Imaging AS, Oslo, Norway. cgt@nycomed.com
Purpose:
To evaluate the diagnostic efficacy and safety of MnDPDP (Teslascan) in enhanced MR imaging.
Material And Methods:
In 2 multiple independent trials in Europe 624 patients were given MnDPDP intravenously at 5 mumol/kg b.w. Patients underwent an unenhanced MR examination comprising T1-weighted spin-echo and breath-hold gradient-echo sequences and a T2-weighted spin-echo sequence. The T1 sequences were repeated after the administration of MnDPDP. In a subgroup of 137 patients the results of the enhanced MR images were compared with the results of contrast-enhanced CT (CECT) images.
Results:
For both types of T1-weighted sequences and when evaluating the maximum numbers of lesions seen in all imaging sequences, the total numbers of lesions seen were significantly higher in the MnDPDP-enhanced images than in the unenhanced images (p = 0.0005 and p = 0.0001, respectively). The investigators considered the enhanced images to contain "other additional information not found in the unenhanced images" in 279 (45%) of the 621 patients examined. The MnDPDP-enhanced images were also superior to the CECT images in the detection of lesions (p = 0.02). Adverse events were reported by 46 patients (7%) and infusion-associated discomfort by 26 (4%). Heart rates and systolic and diastolic blood pressures showed no clinically significant changes from baseline as a result of the administration of the contrast medium.
Conclusion:
MnDPDP was shown to be effective and safe in enhanced MR imaging of the liver.
Insights
Gadolinium-based contrast agent manganese dipyridoxyl diphosphate (MnDPDP) significantly improves lesion detection in liver MRI. This enhanced MR imaging is safe and effective, outperforming unenhanced scans and contrast-enhanced CT.
Area of Science:
- Radiology
- Medical Imaging
- Hepatology
Background:
- Magnetic Resonance Imaging (MRI) is a key diagnostic tool.
- Contrast agents enhance image quality and diagnostic information.
- Manganese dipyridoxyl diphosphate (MnDPDP) is a novel MRI contrast agent.
Purpose of the Study:
- To assess the diagnostic efficacy of MnDPDP (Teslascan) in enhanced MRI.
- To evaluate the safety profile of MnDPDP in clinical use.
- To compare MnDPDP-enhanced MRI with unenhanced MRI and contrast-enhanced CT (CECT).
Main Methods:
- Two independent European trials involving 624 patients.
- Intravenous administration of MnDPDP at 5 μmol/kg.
- Comparison of enhanced MRI sequences with unenhanced MRI and CECT in a subgroup of 137 patients.
Main Results:
- MnDPDP-enhanced MRI significantly increased lesion detection compared to unenhanced MRI (p = 0.0005 and p = 0.0001).
- Additional diagnostic information was found in 45% of patients on enhanced images.
- MnDPDP-enhanced MRI demonstrated superiority over CECT in lesion detection (p = 0.02).
- Adverse events were reported in 7% of patients, with no clinically significant changes in vital signs.
Conclusions:
- MnDPDP is an effective contrast agent for liver MRI.
- The safety profile of MnDPDP is favorable for enhanced MR imaging.
- MnDPDP improves diagnostic accuracy in liver lesion detection.