Completed PHASE3 INTERVENTIONAL 3-arm NCT00522951

SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study

Multi-center, Randomized, Controlled, Single-blind, Intra-individual Comparisons of 2 Dose of Gadobutrol 1.0 Molar and Gadoteridol (ProHance) Crossover Studies With Corresponding Blinded Image Evaluation Following Multiple Injections of 0.1 mmol/kg bw of Gadobutrol and Gadoteridol in Patients With Known or Suspected Brain Metastasis

Sponsor: Bayer

Conditions Brain Metastases

Interventions Gadobutrol (Gadavist, Gadovist, BAY86-4875) ProHance

Updated 6 times since 2017 Last updated: Jul 28, 2017 Started: Aug 31, 2007 Primary completion: Aug 31, 2008 Completion: Aug 31, 2008

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

This PHASE3 trial investigates Brain Metastases and is currently completed. Bayer leads this study, which shows 6 recorded versions since 2007 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

6 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 1 earlier version

Jan 2017 — Jun 2018 [monthly]

Completed PHASE3

First recorded

Aug 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

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

Bunkyo-ku, Japan , Chuo-ku, Japan , Fukuoka, Japan , Habikino, Japan , Hamamatsu, Japan , Kitakyushu, Japan , Kobe, Japan , Matsuyama, Japan , Mitaka, Japan , Nagoya, Japan and 8 more locations