Initial imaging recommendations for Vasovist angiography.

Vasovist is a newly developed blood pool contrast agent for MR angiogiography (MRA). It consists of a low molecular weight molecule, chelated to Gadolinium, that strongly binds to plasma proteins, thus increasing its relaxivity and retention time in the vascular system. Due to its high efficiency, a smaller dose compared to existing Extracellular Fluid Contrast Agents is sufficient for diagnostic purposes, resulting in a lower injection volume. With appropriate adjustments of standard extracellular contrast injection protocols, a dynamic phase MRA can be achieved using routine MRA parameters. For extended phase imaging, ('steady-state') starting approximately 3 to 5 min post injection, repetition time (TR) and flip angle may be adjusted for optimization of intravascular signal. Preliminary technical recommendations for the optimization of contrast-enhanced MRA with Vasovist can be deducted from current clinical trial experience in various vessel beds.

Gadobenate dimeglumine-enhanced magnetic resonance angiography of the pelvic arteries.

RATIONALE AND OBJECTIVES: To evaluate 4 doses of gadobenate dimeglumine (Gd-BOPTA) for contrast-enhanced magnetic resonance angiography (CE-MRA) of the pelvic arteries and to compare CE-MRA with unenhanced time-of-flight MRA (2D-TOF-MRA). METHODS: A multicenter Phase II dose-finding study was performed in 136 patients with Gd-BOPTA doses of 0.025, 0.05, 0.1, and 0.2 mmol/kg bodyweight. Evaluation of CE-MRA images and comparison with 2D-TOF-MRA images was performed onsite and by 2 blinded offsite reviewers in terms of subjective image quality, number of lesions detected, and confidence in lesion characterization. RESULTS: Significant (P < 0.05) improvements over unenhanced findings were observed for CE-MRA at all dose levels. For reviewer 1 and the onsite investigators, the overall image quality increased up to a dose of 0.1 mmol/kg and then plateaued. For reviewer 2, increased image quality was noted up to a dose of 0.2 mmol/kg. Significant (P < 0.005) increases in diagnostic confidence on CE-MRA versus unenhanced MRA was observed for all dose groups by reviewer 1 and the onsite investigators and for the 0.1 and 0.2 mmol/kg dose groups by reviewer 2. No serious adverse events were recorded that were attributable to the study drug and no trends in laboratory parameters, vital signs, or electrocardiogram recordings were observed. CONCLUSIONS: Gadobenate dimeglumine-enhanced MRA is safe and significantly more effective than unenhanced 2D-TOF-MRA for imaging the pelvic arteries. A dose of 0.1 mmol/kg appears the most appropriate dose for subsequent Phase III clinical evaluation.

Contrast-enhanced MR angiography of the run-off vasculature: intraindividual comparison of gadobenate dimeglumine with gadopentetate dimeglumine.

PURPOSE: To compare intraindividually gadobenate dimeglumine (Gd-BOPTA) with gadopentetate dimeglumine (Gd-DTPA) for multi-station MR Angiography of the run-off vessels. MATERIALS AND METHODS: Twenty-one randomized healthy volunteers received either Gd-BOPTA or Gd-DTPA as a first injection and then the other agent as a second injection after a minimum interval of 6 days. Each agent was administered at a dose of 0.1 mmol/kg bodyweight followed by a 25-mL saline flush at a single constant flow rate of 0.8 mL/second. Images were acquired sequentially at the level of the pelvis, thigh, and calf using a fast three-dimensional (3D) gradient echo sequence. Source, subtracted source, maximum intensity projection (MIP), and subtracted MIP image sets from each examination were evaluated quantitatively and qualitatively on a segmental basis involving nine vascular segments. RESULTS: Significantly (P < 0.05) higher signal-to-noise and contrast-to-noise ratios were noted for Gd-BOPTA compared to Gd-DTPA, with the more pronounced differences evident in the more distal vessels. Qualitative assessmentrevealed no differences in the abdominal vasculature, a preference for Gd-BOPTA in the pelvic vasculature, and markedly better performance for Gd-BOPTA in the femoral and tibial vasculature. Summation of individual diagnostic quality scores for each segment revealed a significantly (P = 0.0001) better performance for Gd-BOPTA compared to Gd-DTPA. CONCLUSION: Greater vascular enhancement of the run-off vasculature is obtained after Gd-BOPTA, particularly in the smaller more distal vessels. Enhancement differences are not merely dose dependent, but may be due to different vascular enhancement characteristics of the agents.

Gadobenate dimeglumine-enhanced MR angiography of the abdominal aorta and renal arteries.

OBJECTIVE: This study was conducted to determine the efficacy and safety of four different doses of gadobenate dimeglumine for contrast-enhanced three-dimensional MR angiography of the abdominal aorta and renal arteries. SUBJECTS AND METHODS: Ninety-four patients with suspected abnormality of the abdominal aorta or renal arteries underwent unenhanced three-dimensional gradient-recalled echo time-of-flight MR angiography and contrast-enhanced MR angiography after the IV injection of one of four doses of gadobenate dimeglumine (0.025, 0.05, 0.1, and 0.2 mmol/kg of body weight). Efficacy was assessed on-site and by two blinded off-site reviewers in terms of change in total diagnostic quality score and diagnostic quality score per vessel segment from baseline unenhanced time-of-flight MR angiography to contrast-enhanced MR angiography. Secondary efficacy end points included lesion count and level of confidence in lesion characterization. Safety assessments comprised adverse event monitoring, physical evaluation, vital signs, ECG, and laboratory investigations. RESULTS: A significant change in the total diagnostic quality score from unenhanced to contrast-enhanced MR angiography was observed at all doses. The change increased with increased dose, plateauing at the 0.1 mmol/kg dose level. More patients with lesions detected and increased reviewer confidence for lesion characterization were noted on contrast-enhanced MR angiography compared with unenhanced MR angiography, although no dose-related trends were observed. All doses were well tolerated, and no significant changes in safety parameters were observed. CONCLUSION: Gadobenate dimeglumine is an effective and safe agent for contrast-enhanced MR angiography of the abdominal aorta and renal arteries. A dose of 0.1 mmol/kg of body weight appears to be the most suitable.