Phase 3 N=165 Randomized Single-blind Diagnostic

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

Brain Metastases

Bottom Line

View on ClinicalTrials.gov: NCT00522951 ↗

Enrolled (actual)

165

Serious AEs

0.6%

Results posted

Aug 2011

Primary outcome: Primary: Number of Lesions Detected by Blinded Readers (BR) and Investigator — 6.28; 6.92; 6.87; 6.36 lesions

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Gadobutrol (Gadavist, Gadovist, BAY86-4875) (Drug); ProHance (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Bayer
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Lesions Detected by Blinded Readers (BR) and Investigator	6.28; 6.92; 6.87; 6.36; 6.87; 6.66	—
SECONDARY Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader	3.44; 3.54; 3.51	—
SECONDARY Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator	3.16; 3.46; 3.31	—
SECONDARY Score of Visibility Assessment - Border Delineation by Blinded Reader	3.30; 3.45; 3.36	—
SECONDARY Score of Visibility Assessment - Border Delineation by Investigator	3.10; 3.38; 3.22	—
SECONDARY Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE)	0; 2; 0; 1; 148; 0	—
SECONDARY Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator	1; 0; 0; 0; 149; 0	—
SECONDARY Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE	0; 1; 0; 0; 150; 0	—
SECONDARY Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator	1; 0; 0; 0; 149; 0	—
SECONDARY Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE	26; 22; 15; 10; 24; 30	—
SECONDARY Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator	9; 24; 21; 5; 58; 59	—
SECONDARY Number of Participants With Reasons for Performance in SRS Planning by TPE	2; 5; 1; 0; 5; 3	—
SECONDARY Number of Participants With Reasons for Performance in SRS Planning by Investigator	2; 8; 0; 1; 6; 17	—
SECONDARY Lesion Size Evaluated by Independent Radiologist	8.79; 9.07; 8.83	—
SECONDARY Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist	36.74; 60.09; 53.01	—
SECONDARY Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions	0.963; 0.955; 0.949	—

Summary

This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance, which has already been approved as a pharmaceutical product of similar indication.

Eligibility Criteria

Inclusion Criteria

Japanese patients at least 20 years of age
Patients with diagnosed primary cancer
Patients with metastatic lesions by CT/MRI

Exclusion Criteria

Patients who have contraindication to the MRI examinations
Patients who have severe renal disorder
Patients in extremely serious general condition

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00522951). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.