A Prospective Study to Evaluate the Efficacy and Safety of a Single Intravenous Injection of 0.1 mmol/kg Body Weight of Viv-Butrol for Contrast Enhancement MRI of Various Organs

Introduction: Magnetic Resonance Imaging (MRI) is the diagnostic technique preferred for tissue imaging in conditions like neurological and other abnormalities, as the procedure is able to generate images providing subtle differences between pathological and normal tissues. MRI works with a high-strength magnetic field, radio waves, and computer to generate images and has not been reported to produce any tissue damage or any other side effects. To improve the imaging of tissues, better iodinated and gadolinium-based contrast agents are used. Hypersensitivity reactions to contrast media are generally sporadic and unpredictable. The incidences of mild to moderate reactions are more common for iodinated contrast media than gadolinium-based chelates. Aims and Objectives: To determine the efficacy and safety of a single intravenous injection of 0.1 mmol/kg Body Weight of Viv-Butrol in patients referred for contrast enhancement MRI of various organs, including the brain, spinal cord, breast, liver, and kidney. Materials and Methods: A prospective, single-arm, open-label, multi-center, post-marketing surveillance study with a sample size of 100 was conducted for nine months. The study was conducted at three study centers: Bangalore Medical College and Research Institute, Department of Radio Diagnosis Bengaluru, ESIC Medical College & Hospital, Department of Radiology, Hyderabad, and Rajiv Gandhi Institute of Medical Sciences (RIMS), Srikakulam. Results: It was observed that there was a statistically significant difference (p < 0.05) in Contrast Enhancement, Border Delineation, Internal Mor- phology, and Total Mean Score post-administration of Viv-Butrol. Conclusion: For several years, Gadolinium agents have been used worldwide for Contrast MRI. MRI with gadolinium contrasts is relatively much safer than iodinated contrast media, while establishing the efficacy of Gadobutrol and establishing the safety parameters also becomes essential. The study result shows that Viv-Butrol-enhanced MRI has been established to have much better efficacy when compared to its unenhanced/plain MRI with minimal Adverse reactions.