Bracco Neuroimaging Clinical Trial Project
Principal Investigator:
Geoffrey Young, M.D.
Section of Neuroradiology
Radiology Department at Brigham and Women's Hospital
A Phase IV, Double-Blind, Multi-Center, Randomized, Cross-over Study to Compare 0.10 mmol/kg of MultiHance® with 0.10 mmol/kg of Magnevist® in Magnetic Resonance Imaging (MRI) of the Brain at 3.0 T.
The growing demand for radiological consultation in clinical applications and medical treatment has created a gap between what is required from non-invasive medical imaging and what is possible by non-invasive medical imaging. For imaging modalities such as magnetic resonance imaging (MRI), the usage of gadolinium-based contrasting agents such as Magnevist® has helped to lessen this gap by allowing radiologists to visualize extracellular spaces and vascular networks clearly. As pathology and the treatment for malignancies evolve, so must the way in which they are seen. While contrast agents such as Magnevist® have provided a foundation for MR imaging, improvements can be made in the representation of contrast-enhanced images as well as the prevention of adverse events in patients using gadolinium-based enhancing solutions.
To evaluate the efficacy of Multihance® compared to conventional Gd agents to Magnevist® as the aforementioned doses in terms of the by-patient global diagnostic preference between exams (i.e., based on predose and postdose image sets). Additionally, this study will compare these two different investigational products at the abovementioned doses in terms of by-patient global preference between exams with regards to border delineation and contrast (conspicuity) of lesions. Furthermore, this study will evaluate the different investigational compounds at the specified doses in terms of global change in lesion count between exams. Quantitatively, this study will compare the lesion-to-background ratio (LBR), the contrast-to-noise ratio (CNR), and the percent contrast enhancement by lesion for all visible lesions. This study will focus on patients who are highly suspected to have brain tumors, determined by clinical symptomatology or diagnostic testing. Specific malignancies included in this study will cover intra-axial brain tumors, such as glioma and brain metastasis (single or two mets preferred), while excluding patients with pituitary tumors, infarcts, and multiple mets too numerous to count. Patients with acoustic neuromas and meningiomas will also be limited in their inclusion in this study.
Send Feedback to: 
