MultiHance (R) in the assessment of intracranial tumors: Results of phase II clinical studies

Purpose: To assess preliminarily the efficacy of 0.1 and 0.2 mmol/kg doses of MultiHance(R) for contrast-enhanced magnetic resonance imaging of brain tumors. Methods: Patients were imaged pre-dose using proton density (PD), T2-weight ed and T1-weighted spin-echo sequences, and post-dose by repetition of the T1-weighted sequences at 0-15, 15-30, 30-45 and 45-60 min after the complet ion of MultiHance(R) administration. Qualitative efficacy assessments of th e image sets were performed by two blinded neuroradiologists in terms of th e level of diagnostic information, the type of additional information provi ded by post-contrast images, the best post-contrast image set in terms of d iagnostic information, the radiological utility of MultiHance(R), and the d etectability of brain metastases. Extensive safety and tolerability control s were performed at 3 and 24 h post-contrast. Results: Additional diagnostic information was available on MultiHance(R)-e nhanced images as compared to pre-contrast images for 58.6-78.9% of patient s administered 0.1 mmol/kg MultiHance(R) and 66.1-74.6% of patients adminis tered 0.2 mmol/kg MultiHance(R). Generally, the early (0 to 30 min) post-co ntrast image sets were preferred, with a clear superiority at the 15-30 min post-dose time point. In a subgroup of 21 patients with brain metastases, a higher number of lesions was detected in 55.6-66.7% of the cases with 0.1 mmol/kg MultiHance(R) and in 58.3% of the cases with 0.2 mmol/kg MultiHanc e(R). Overall, the usefulness of MultiHance(R) was judged as good to excell ent in 91.4% of the patients at both dose levels. A total of 12 of 120 pati ents (10%) reported 15 transient, self-resolving adverse events of mild-to- moderate intensity. No difference between doses was observed in the inciden ce of adverse events and no laboratory ECG or vital signs abnormalities wer e reported. Conclusion: MultiHance(R) is a safe and effective contrast agent for magnet ic resonance assessment of brain tumors when administered intravenously at doses up to 0.2 mmol/kg.