Completed PHASE3 INTERVENTIONAL 2-arm NCT05915702

A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Known or Suspected Brain or Spinal Cord-related Problems (Quanti CNS)

A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of the Central Nervous System (CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Sponsor: Bayer

Conditions Central Nervous System Pathology Contrast Enhancement in Magnetic Resonance Imaging

Interventions Gadobutrol Gadoquatrane (BAY1747846) Gadoterate meglumine Gadoteridol

Updated 14 times since 2023 Last updated: Aug 15, 2025 Started: Jul 24, 2023 Primary completion: May 30, 2024 Completion: May 31, 2024

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05915702, this PHASE3 trial focuses on Central Nervous System Pathology and Contrast Enhancement in Magnetic Resonance Imaging and remains completed. Sponsored by Bayer, it has been updated 14 times since 2023, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

14 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Jun 2025 — Sep 2025 [monthly]

Completed PHASE3
Sep 2024 — Jun 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3

Status: Recruiting → Completed
Jun 2024 — Jul 2024 [monthly]

Recruiting PHASE3

▶ Show 9 earlier versions

May 2024 — Jun 2024 [monthly]

Recruiting PHASE3
Mar 2024 — May 2024 [monthly]

Recruiting PHASE3
Feb 2024 — Mar 2024 [monthly]

Recruiting PHASE3
Jan 2024 — Feb 2024 [monthly]

Recruiting PHASE3
Dec 2023 — Jan 2024 [monthly]

Recruiting PHASE3
Oct 2023 — Dec 2023 [monthly]

Recruiting PHASE3
Sep 2023 — Oct 2023 [monthly]

Recruiting PHASE3
Aug 2023 — Sep 2023 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Jul 2023 — Aug 2023 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Bayer

Data source: Bayer

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Andria, Italy , Ankara, Turkey (Türkiye) , Augsburg, Germany , Beijing, China , Bergamo, Italy , Brno, Czechia , Busan, South Korea , CABA, Argentina , Cardiff, United Kingdom , Chicago, United States and 51 more locations