Clinical Trials Logo
  1. Home
  2. Magnetic Resonance Imaging
  3. NCT03602339

Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose — LEADER 75  

Magnetic Resonance Imaging Clinical Trial

Official title:
LowEr Administered Dose With highEr Relaxivity: Gadovist vs Dotarem (LEADER 75)

Clinical Trial Summary

The study was conducted to gain knowledge about a new dose of a diagnostic drug that is used for contrast-enhanced Magnetic Resonance Imaging (MRI) of the human central nervous system (CNS). MRI can visualize the anatomy of the body and is used to detect medical conditions. Diagnostic drugs like gadobutrol and gadoterate contain an element called gadolinium that is applied to improve the analysability of MRI-images. The purpose of this study was to examine if contrast-enhanced MRI using a reduced dose of the gadolinium-based contrast agent gadobutrol delivers images of similar quality to those obtained when a full dose of the gadolinium-based contrast agent gadoterate was used.

Clinical Trial Description

The study was an open-label, multi-center, comparative, cross-over trial in adult patients with known or highly suspected CNS pathology who were referred for imaging of the CNS. The primary objective of the study was to demonstrate the non-inferiority of gadobutrol (0.075 mmol/ kg body weight) to gadoterate (0.1 mmol/ kg body weight). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03602339
Study type Interventional
Source Bayer
Contact
Status Completed
Phase Phase 4
Start date November 14, 2018
Completion date May 26, 2020
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03785171 - Predicative Value of Multimodal MRI in Moyamoya Disease
Not yet recruiting NCT03726788 - Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis Phase 2
Active, not recruiting NCT01956409 - Proton MR Spectroscopy and 18F-Fluorocholine PET for Breast Cancer Diagnosis Phase 4
Completed NCT01660841 - Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects for CNS Imaging Phase 3
Recruiting NCT03635619 - The Application of 3T MRI in Esophageal Cancer
Recruiting NCT03658343 - T2* MRI Analysis for Sarcoma N/A
Recruiting NCT04555642 - Early Diagnosis of Therapy-associated Cardiotoxicity Basing on Multi-tracer Multimodality PET/MRI
Active, not recruiting NCT03441867 - Neuroimaging Biomarker for Seizures N/A
Recruiting NCT04850001 - Cognitive Decline in Asymptomatic Intracranial Stenosis Patients: A 1-Year Follow-Up Study
Not yet recruiting NCT05816213 - Point-of-care Low-field MRI in Acute Stroke
Active, not recruiting NCT05498623 - MR Fingerprinting for Diagnostic of Prostate Cancer
Recruiting NCT04257747 - Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI N/A
Recruiting NCT04996615 - Artificial Intelligence Analysis for Magnetic Resonance Imaging in Screening Breast Cancer in High-risk Women
Recruiting NCT05889117 - Brain Stimulation for Concussion N/A
Completed NCT02540967 - Drug Use Investigation of Gadovist.
Completed NCT05103189 - 4D-flow Cardiac MRI to Assess Pulmonary Arterial Pressure in Pulmonary Hypertension N/A
Completed NCT02567318 - Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia? N/A
Recruiting NCT02834585 - Magnetic Resonance Imaging or Ultrasound in Soft Tissue Tumors (MUSTT) N/A
Active, not recruiting NCT02446665 - Disease Status in Primary Sclerosing Cholangitis by Elastography N/A
Completed NCT01721785 - Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer N/A