SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study
- Conditions
- Brain Metastases
- Interventions
- Registration Number
- NCT00522951
- Lead Sponsor
- Bayer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
- Japanese patients at least 20 years of age
- Patients with diagnosed primary cancer
- Patients with metastatic lesions by CT/MRI
- Patients who have contraindication to the MRI examinations
- Patients who have severe renal disorder
- Patients in extremely serious general condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Gadobutrol 0.2 mmol/kg bw Gadobutrol (Gadavist, Gadovist, BAY86-4875) Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min Gadobutrol 0.1 mmol/kg bw Gadobutrol (Gadavist, Gadovist, BAY86-4875) Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw Gadoteridol (ProHance) ProHance Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
- Primary Outcome Measures
Name Time Method Number of Lesions Detected by Blinded Readers (BR) and Investigator one day Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator
- Secondary Outcome Measures
Name Time Method Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator one day Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)
Score of Visibility Assessment - Border Delineation by Investigator one day Border delineation for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=None, 2=Moderate, 3=Good, 4=Excellent)
Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE) one day Treatment planning confidence evaluated separately for each image set (gadobutrol \[Gado-\] 0.1 mmol/kg bw and gadoteridol \[Pro-\] 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable)
Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator one day Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable)
Lesion Size Evaluated by Independent Radiologist one day Size of each lesion on postcontrast MR images evaluated by independent radiologist (mean and standard deviation of 603 lesions)
Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader one day Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)
Score of Visibility Assessment - Border Delineation by Blinded Reader one day Border delineation for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=None, 2=Moderate, 3=Good, 4=Excellent)
Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator one day Treatment planning confidence evaluated separately for each image set (gadobutrol 0.1 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable)
Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE one day Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable)
Number of Participants With Reasons for Performance in SRS Planning by TPE one day Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)
Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator one day Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator
Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist one day CNR of lesion/normal white matter based on the signal intensity of MR images evaluated by independent radiologist (mean and standard deviation of 306 lesions)
Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions one day ICC among 3 blinded readers calculated for number of detected lesions using the statistical model with two random effects, i.e., blinded readers and individual patients.
Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE one day Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by TPE
Number of Participants With Reasons for Performance in SRS Planning by Investigator one day Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)