Double-blind, efficacy evaluation of gadobenate dimeglumine, a gadolinium chelate with enhanced relaxivity, in malignant lesions of the brain.

BACKGROUND AND
PURPOSE: The diagnostic efficacy of gadobenate dimeglumine (Gd BOPTA) was compared with that of gadodiamide (Gd DTPA-BMA) in patients with primary malignant tumors or metastases of the brain.
METHODS: A subset of patients was evaluated from the 410 enrolled in the United States in phase III central nervous system clinical trials with gadobenate dimeglumine. From these trials, there were 82 patients with intraaxial malignant neoplasms of the brain, the focus of the current study. Patients were randomized to one of three incremental dosing regimens. Imaging with gadodiamide at doses of 0.1 and 0.3 mmol/kg was compared with gadobenate dimeglumine at doses of 0.05 and 0.15 mmol/kg and at doses of 0.1 and 0.2 mmol/kg. The on-site physician, patient, and all off-site reviewers were blinded to the agent injected and the administered dose. Scans were obtained before contrast administration and within 5 minutes after administration of each dose. The two contrast injections in any one patient were separated by 15 minutes. An independent laboratory performed signal intensity measurements. The magnetic resonance (MR) films were evaluated for level of diagnostic information, number of lesions detected, and confidence in MR imaging diagnosis by two independent board-certified neuroradiologists unaffiliated with any study site.
RESULTS: The lesion-to-brain signal intensity ratio after a dose of 0.1 mmol/kg gadobenate dimeglumine was higher than that after a dose of 0.1 mmol/kg gadodiamide, with this result statistically significant (P = 0.02). After the second dose of contrast, results were comparable in all three groups. The level of diagnostic information contained on the MR films increased significantly for all three groups from pre- to postcontrast for both the first and second administered doses. In between-group comparisons, the level of diagnostic information was similar after the first contrast dose for all three dosing regimens. This was also true after the second contrast dose. For all three groups, the number of lesions detected increased significantly postdose (whether first or second). Confidence in MR diagnosis increased from predose to postdose for all three groups, with no statistically significant difference between groups.
CONCLUSION: Gadobenate dimeglumine, used at slightly lower doses, is comparable to gadodiamide in terms of efficacy in imaging of malignant intraaxial brain lesions. As with other gadolinium chelates, higher doses (0.15 and 0.2 mmol/kg) of gadobenate dimeglumine offer greater diagnostic information.

RCT Entities:   Population Interventions Outcomes