Study 22403 is a Phase 1 / Proof of Concept exploratory investigation to assess the non-inferiority of low dose gadobutrol and SubtleGAD™, a software medical device using an Artificial Intelligence (AI) deep learning-based method to enhance the contrast signal from images acquired with low dose administration of gadobutrol (GAD) contrast. The primary objective is to demonstrate noninferiority of synthesized Central Nervous System (CNS) magnetic resonance (MR) images for 1 or 2 different gadobutrol-enhanced low-dose groups (0.01mmol/kg, and0.025 mmol/kg) compared to gadobutrol-enhanced CNS MR images at a standard dose of 0.1 mmol/kg. This investigation is a prospective, randomized, open label, multi-center study with blinded reads in participants with known or highly suspected CNS pathology. There will be at least 60 participants enrolled (30 per study arm). SubtleGAD will be used as a post-processing tool, prior to blinded read assessment of MR images acquired in either arm of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
SubtleGAD is an image processing software developed to enhance MR images acquired with low dose gadobutrol.
Gadavist is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients including term neonates to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.
Central Illinois Radiological Associates; OSF St. Francis Hospital Peoria
Peoria, Illinois, United States
UMass Chan Medical School
Worcester, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
The Pennsylvania State University
State College, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Compare enhancement of SubtleGAD in 10% dose and 25% dose gadobutrol MR images.
Compare enhancing lesions in gadobutrol-enhanced central nervous system (CNS) magnetic resonance imaging (MRI) low dose groups (0.01 mmol/kg, 0.025 mmol/kg), and standard dose (0.1 mmol/kg).
Time frame: 4 to 15 days
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