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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
165
Gadobutrol enhanced MRI (first injection of gadobutrol 0.1 mmol/kg bw, corresponding to a dose of 0.1 mmol/kg bw)
Gadobutrol enhanced MRI (second injection of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)
ProHance enhanced MRI (two injections of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Matsuyama, Ehime, Japan
Unnamed facility
Kitakyushu, Fukuoka, Japan
Number of Lesions Detected by Blinded Readers (BR) and Investigator
Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator
Time frame: one day
Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader
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)
Time frame: one day
Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator
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)
Time frame: one day
Score of Visibility Assessment - Border Delineation by Blinded Reader
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)
Time frame: one day
Score of Visibility Assessment - Border Delineation by Investigator
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)
Time frame: one day
Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE)
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)
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Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Kobe, Hyōgo, Japan
Unnamed facility
Sagamihara, Kanagawa, Japan
Unnamed facility
Yokohama, Kanagawa, Japan
Unnamed facility
Habikino, Osaka, Japan
Unnamed facility
Habikino, Osaka, Japan
Unnamed facility
Sayama, Osaka, Japan
...and 10 more locations
Time frame: one day
Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator
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)
Time frame: one day
Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE
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)
Time frame: one day
Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator
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)
Time frame: one day
Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE
Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by TPE
Time frame: one day
Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator
Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator
Time frame: one day
Number of Participants With Reasons for Performance in SRS Planning by TPE
Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)
Time frame: one day
Number of Participants With Reasons for Performance in SRS Planning by Investigator
Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)
Time frame: one day
Lesion Size Evaluated by Independent Radiologist
Size of each lesion on postcontrast MR images evaluated by independent radiologist (mean and standard deviation of 603 lesions)
Time frame: one day
Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist
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)
Time frame: one day
Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions
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.
Time frame: one day