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Trial intelligence / Profile preview
Quanti CNS
NCT05915702Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2023
- Primary completion
- May 2024
- Countries
- 15
- Sponsor
- Bayer
- Drugs
- gadoquatrane
- Conditions
- central nervous system conditions (CNSD)
01
Overview
Phase 3, randomised, double-blind trial of gadoquatrane in central nervous system conditions (CNSD) (2 arms), sponsored by Bayer. Primary endpoints: Visualization Parameter Contrast Enhancement Assessed by Separate Blinded Evaluation at 1 day, Visualization Parameter Delineation Assessed by Separate Blinded Evaluation at 1 day and 1 more. Started Jul 2023; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Gadoquatrane - Approved Macrocyclic GBCA
Gadoquatrane in Period 1, Approved Macrocyclic GBCA in Period 2
Approved Macrocyclic GBCA - Gadoquatrane
Approved Macrocyclic GBCA in Period 1, Gadoquatrane in Period 2
03
Who it enrols
Adults with known or suspected CNS pathology requiring a contrast-enhanced MRI, with eGFR >= 30 mL/min/1.73m^2.
04
Endpoints
Primary
Visualization Parameter Contrast Enhancement Assessed by Separate Blinded Evaluation
Visualization Parameter Delineation Assessed by Separate Blinded Evaluation
Visualization Parameter Morphology Assessed by Separate Blinded Evaluation
Secondary
Sensitivity for the Detection of Lesions
Specificity for the Detection of Lesions
Mean Overall Diagnostic Clinical Value Score
Number of Participants With Treatment Emergent Adverse Events
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