A clinical comparison of the safety and efficacy of MultiHance (gadobenate dimeglumine) and Omniscan (Gadodiamide) in magnetic resonance imaging in patients with central nervous system pathology.

RATIONALE AND OBJECTIVES: The safety and diagnostic efficacy of MultiHance (gadobenate dimeglumine) in the central nervous system (CNS) were evaluated in a double-blind, multicenter, phase III clinical trial. METHODS: Two hundred five patients highly suspected of having a CNS lesion (by previous imaging exam) were enrolled at 16 sites in the United States. Patients were randomized to one of three incremental dosing regimens. Magnetic resonance imaging with Omniscan (gadodiamide) at doses of 0.1 and 0.3 mmol/kg was compared with MultiHance (gadobenate dimeglumine) at doses of 0.05 and 0.15 mmol/kg and at 0.1 and 0.2 mmol/kg. RESULTS: Compared with predose images alone, efficacy was demonstrated in each of the gadobenate dimeglumine and gadodiamide groups (single and cumulative doses) as indicated by the level of diagnostic information, number of lesions detected, and contrast-to-noise ratio measurements. The level of diagnostic information from gadobenate dimeglumine at 0.1 mmol/kg was equivalent to that with gadodiamide at the same dose. One of the two blinded reviewers found equivalence between the gadobenate dimeglumine 0.05 mmol/kg dose and gadodiamide at 0.1 mmol/kg. Both reviewers found the level of diagnostic information to be equivalent after the second dose of contrast for all three dosing regimens. The cumulative doses of gadobenate dimeglumine were well tolerated and as safe as gadodiamide. CONCLUSIONS: Gadobenate dimeglumine is comparable to gadodiamide in terms of safety and efficacy for imaging of CNS lesions, with a possible advantage in imaging applications owing to enhanced T1 relaxivity.

Efficacy and safety of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults: results of the U.S. Multicenter phase III clinical trials. Efficacy of early imaging.

The efficacy of contrast-enhanced magnetic resonance imaging (MRI) for detecting and characterizing, or excluding, hepatic masses was assessed in 404 patients, following the intravenous administration of mangafodipir trisodium (MnDPDP) injection, a hepatic MRI contrast agent. An initial contrast-enhanced computed tomography (CT) examination was followed by unenhanced MRI, injection of MnDPDP (5 micromol/kg IV), and enhanced MRI at 15 minutes post injection. Agreement of the radiologic diagnoses with the patients' final diagnoses was higher for enhanced MRI and for the combined unenhanced and enhanced MRI evaluations than for unenhanced MRI alone or enhanced CT using the clinical diagnosis as the gold standard. Mangafodipir-enhanced MRI uniquely provided additional diagnostic information in 48% of the patients, and patient management was consequently altered in 6% of the patients. MnDPDP-enhanced MRI was comparable or superior to unenhanced MRI and enhanced CT for the detection, classification, and diagnosis of focal liver lesions in patients with known or suspected focal liver disease.

Safety and efficacy of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults: results of the U.S. multicenter phase III clinical trials (safety).

The short-term safety of mangafodipir trisodium (MnDPDP) injection was studied in 546 adults with known or suspected focal liver lesions. An initial contrast-enhanced computed tomography examination was followed by unenhanced magnetic resonance imaging (MRI), injection of MnDPDP (5 micromol/kg), and enhanced MRI. Adverse events were reported for 23% of the patients; most were mild to moderate in intensity, did not require treatment, and were not drug related. The most commonly reported adverse events were nausea (7%) and headache (4%). The incidence of serious adverse events was low (nine events in six patients) and not drug related. Injection-associated discomfort was reported for 69% of the patients, and the most commonly reported discomforts included heat (49%) and flushing (33%). Changes in laboratory values and vital signs were generally transient, were not clinically significant, and did not require treatment. There were no clinically significant short-term risks from exposure to MnDPDP.

Cerebral imaging in the asymptomatic preoperative bronchogenic carcinoma patient: is it worthwhile?

The issue of screening for cerebral metastatic disease in the preoperative bronchogenic carcinoma patient remains unsettled and changes with advancing technology. A prospective nonrandomized study was designed to compare contrast magnetic resonance imaging (MRI) with computed tomography (CT) after several clinical situations suggested improved sensitivity for the former study. Patients with clinically operable disease and normal neurologic examinations were referred for both enhanced cerebral CT and MRI studies. Forty-two patients were entered and completed the enhanced CT scan; only 30 tolerated the MRI. The demographic data and histology of the patients appeared fairly typical for a series of operative candidates. No unsuspected metastatic lesion was found in this selected and low-risk group. We conclude that neither MRI nor enhanced CT scan is indicated in the asymptomatic bronchogenic carcinoma patient due to expense and lack of positive findings. Magnetic resonance imaging demonstrated more subtle benign pathology, but this study did not allow comparison of the two techniques in detection of metastatic disease.

Assessment of MR angiography versus arteriography for evaluation of cervical carotid bifurcation disease.

PURPOSE: To assess the accuracy of MR angiography alone in screening for vascular stenosis of the common carotid bifurcation. METHODS: Two hundred two common carotid bifurcations in 101 patients were evaluated with MR angiography and selective contrast arteriography. A two-dimensional time-of-flight pulse sequence was used to obtain sequential transverse images through the common carotid bifurcations. These images were reprojected with a maximum intensity pixel ray-tracing algorithm. Both examinations were blindly graded as either normal or mildly stenotic (0%-29%), moderately stenotic (30%-69%), severely stenotic (70%-99%), or occluded. RESULTS: Of the 202 common carotid bifurcations, 119 were classified as normal-mild stenosis by contrast arteriography. In this category, MR angiography correctly identified 114 of these as normal to mild stenosis. Among 21 common carotid bifurcations graded as moderate stenosis by arteriography, 15 were correctly graded as moderate by MR angiography. Among 45 common carotid bifurcations graded as severe stenosis by arteriography, 41 of these were correctly graded as severe by MR angiography. There were 17 complete occlusions which were all correctly graded by MR angiography. CONCLUSION: MR angiography with its high rate of agreement with contrast arteriography can be regarded as an accurate screening method of the common carotid bifurcation.