Safety assessment of gadopentetate dimeglumine in U.S. clinical trials

Article Abstract:

Contrast media are substances given to patients undergoing diagnostic imaging to help enhance the images. It important that both the safety and effectiveness of such agents are established before they are given to patients. Gadopentetate dimeglumine is a contrast agent used to enhance magnetic resonance (MR) images of the brain. This study examined the safety of this contrast agent. Results of clinical trials performed in the US between 1984 and 1988 examining the safety of this agent were combined. Only one of the studies used placebo controls in comparing results, with the others using the patients themselves as controls. In all, 1,068 patients received gadopentetate dimeglumine and 29 received a placebo. Patients were monitored for adverse reactions to the drug or the placebo. Adverse reactions were reported in 213 (19.9 percent) of the patients who received gadopentetate dimeglumine and in 6 (20.7 percent) of the patients receiving the placebo. Severe adverse reactions were reported in 18 (2 percent) of those receiving gadopentetate dimeglumine and in two patients who received the placebo. In the 18 patients reporting severe reactions after receiving gadopentetate, 25 adverse reactions were reported, of which 15 were considered unrelated to the agent. Tests monitoring patient vital signs showed no adverse responses to the agent except for a short-lived rise in serum iron levels in some patients. These results indicate that gadopentetate dimeglumine is very safe and well-tolerated by patients undergoing diagnostic imaging. (Consumer Summary produced by Reliance Medical Information, Inc.)

Evaluation, Complications and side effects, Contrast media, Contrast media (Chemicals), Paramagnetic contrast media

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Three-dimensional reconstructed MR imaging of the inner ear

Article Abstract:

Magnetic resonance (MR) imaging is a useful, noninvasive technique for imaging tissues, organs or structures in the body. It is very helpful in the diagnosis of disease. One major problem with MR is its lack of quantitative abilities stemming from its two-dimensional nature. Recent work has focused on using two-dimensional MR images to reconstruct three-dimensional images. This study examined the use of the fast imaging with steady precession (FISP) method of MR to reconstruct a three-dimensional image of the inner ear. Fifty inner ears were studied using MR. Twenty were normal ears, 10 were ears with malformations, and 20 were ears that had been rendered deaf by disease. Images were taken in all three planes. The two-dimensional MR images were then processed by a computer to reconstruct three-dimensional images. Stereoscopic images were then produced by rotating the axis of the reconstructed images. The resulting images produced clearly defined inner ear structures that the two-dimensional images did not show. Images from abnormal ears revealed the reasons for their hearing defects. The results indicate MR could be useful in examining the anatomy of the inner ear and thus in diagnosing and treating diseases of the inner ear. (Consumer Summary produced by Reliance Medical Information, Inc.)

Methods, Magnetic resonance imaging, Anatomy, Ear

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