for contrast-enhanced liver MRI in patients with severe kidney impairment
FDA issued a Complete Response Letter for Ascelia Pharma's Orviglance (manganese chloride tetrahydrate) NDA for contrast-enhanced liver MRI in patients with severe kidney impairment, citing deficiencies in clinical data (image reading process) and product documentation.
Orviglance is a manganese-based agent used to improve the clarity of magnetic resonance imaging (MRI) scans of the liver. It works by temporarily altering the magnetic properties of liver tissue, which helps lesions appear more distinct from healthy tissue. This could potentially provide clearer diagnostic images for patients with severe kidney impairment who cannot tolerate standard contrast agents.
The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in participants with known or suspected focal liver lesions and severe renal impairment. The diagnostic efficacy of Mangoral will be assessed in terms of visualization of detected focal liver lesions in combined MRI (CMRI: combined Mangoral-enhanced and unenhanced MRI) compared to unenhanced MRI.
Source: ClinicalTrials.gov