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Carotid MR angiography: phase II study of safety and efficacy for MS-325
D A Bluemke1, A E Stillman, K G Bis
1Department of Radiology, Johns Hopkins University School of Medicine, 600 N Wolfe St, Baltimore, MD 21287, USA. dbluemke@rad.jhu.edu
Purpose:
To evaluate the safety and efficacy of MS-325 in patients suspected of having carotid arterial disease.
Materials And Methods:
Fifty carotid arteries in 26 patients were imaged with three-dimensional spoiled gradient-recalled-echo magnetic resonance (MR) angiography at 5 and 50 minutes after injection of MS-325. MS-325 was administered intravenously as a single dose of 0.01, 0.03, or 0.05 mmol per kilogram of body weight as determined with a dose randomization scheme for four, nine, and 13 patients, respectively. Safety, including clinical laboratory changes and electrocardiographic monitoring, was assessed until approximately 3 days after injection. Conventional contrast agent-enhanced angiography was used as the standard of reference. Independent readers blinded to the dose interpreted the MR angiographic and conventional images. Images were assessed for location and extent of carotid arterial stenosis.
Results:
There were no severe or serious adverse events. For the determination of clinically significant stenosis (>70%) on the 5-minute images, sensitivity, specificity, and accuracy (P =.07, three-way comparison) were 100%, 100%, and 100%; 63%, 100%, and 88%; and 40%, 75%, and 55% at 0.01, 0.03, and 0.05 mmol/kg, respectively. Sensitivity and specificity for images at 50 minutes after MS-325 administration showed the same trends as the 5-minute images.
Conclusion:
Overall accuracy for MS-325-enhanced carotid MR angiography performed during steady-state conditions of circulating contrast agent approximately 5 minutes after injection was high (88%-100%) at 0.03 and 0.01 mmol/kg. MS-325 was well tolerated at all evaluated doses.
Insights
MS-325 demonstrated high accuracy (88%-100%) for detecting carotid arterial disease via magnetic resonance (MR) angiography. This contrast agent was safe and well-tolerated in patients, showing no severe adverse events.
Area of Science:
- Radiology
- Cardiovascular Imaging
- Medical Diagnostics
Background:
- Carotid arterial disease poses a significant risk for stroke.
- Accurate imaging is crucial for diagnosis and treatment planning.
- Magnetic resonance (MR) angiography offers a non-invasive imaging modality.
Purpose of the Study:
- To assess the safety and efficacy of MS-325 as a contrast agent for MR angiography.
- To evaluate MS-325's performance in detecting carotid arterial stenosis.
Main Methods:
- Twenty-six patients with suspected carotid arterial disease underwent MR angiography.
- MS-325 was administered intravenously at varying doses (0.01, 0.03, 0.05 mmol/kg).
- Images were acquired at 5 and 50 minutes post-injection; safety was monitored for 3 days.
Main Results:
- No severe or serious adverse events were reported with MS-325.
- At 0.01 and 0.03 mmol/kg, accuracy for detecting >70% stenosis was 100% and 88%, respectively.
- Higher doses showed decreased sensitivity and specificity.
Conclusions:
- MS-325 is a safe and effective contrast agent for carotid MR angiography.
- Optimal accuracy was observed at doses of 0.01 and 0.03 mmol/kg.
- Steady-state imaging approximately 5 minutes post-injection yielded high diagnostic accuracy.
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