Last reviewed · How we verify
NCT00764387
Contrast-enhanced MRI Examination of Cerebral Neoplastic Enhancing Lesions: Comparison of Diagnostic Efficacy of Gd-DOTA 0.5M and Gadobutrol 1.0 M at 0.1 mmol/kg Body Weight: Intraindividual Comparison Clinical Study.
Phase 4 trial testing Gadovist® (Gadobutrol, BAY86-4875) in Neoplastic CNS Lesions in 166 participants. Completed in 1 May 2009.
1 May 2009
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 166 |
| Start date | 1 March 2008 |
| Primary completion | 1 May 2009 |
| Estimated completion | 1 May 2009 |
| Sites | 12 locations across Italy |
Drugs / interventions tested
- Gadovist® (Gadobutrol, BAY86-4875) — full drug profile →
- Dotarem (GADOTERATE MEGLUMINE) — full drug profile →
Conditions studied
- Neoplastic CNS Lesions — all drugs for Neoplastic CNS Lesions →
Sponsor
Bayer — full company profile →
Who can join
18 and older, any sex, with Neoplastic CNS Lesions. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The primary analysis will be the comparison of the enhancements characteristics of Gadobutrol and Gd-TOTA on a lesion per lesion basis.
Time frame: October 2007 to November 2008
Sponsor's own description
Study to compare of two contrast agents in imaging brain lesions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00764387
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Bayer trials
Trials by the same sponsor.
- NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
- NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
- NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00764387 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 4 December 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00764387.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing