Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

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

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

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

Gadobutrol enhanced MRI (first injection of gadobutrol 0.1 mmol/kg bw, corresponding to a dose of 0.1 mmol/kg bw)

Gadobutrol (Gadavist, Gadovist, BAY86-4875)

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)

ProHance

Bayer Study Director

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.

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

Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator

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)

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)

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)

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 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 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 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)

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)

Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by TPE

Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator

Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)

Size of each lesion on postcontrast MR images evaluated by independent radiologist (mean and standard deviation of 603 lesions)

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)

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.

Bayer

Participants received two injections (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw.

Gadobutrol Period

Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw.

ProHance Period

includes all participants received treatment

Entire Study Population

Age, Continuous

Sex: Female, Male

Height

Body weight

Lung cancer

Breast cancer

Others

Primary focus

Therapeutic Area Head

averaged blinded reader

investigator

Gadobutrol 0.1 mmol/kg bw

Gadobutrol 0.2 mmol/kg bw

Gadoteridol (ProHance) 0.2mmol/kg bw

Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.

Number of Lesions Detected by Blinded Readers (BR) and Investigator

Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader

Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator

Score of Visibility Assessment - Border Delineation by Blinded Reader

Score of Visibility Assessment - Border Delineation by Investigator

Gado-not confident, Pro-not confident

Gado-not confident, Pro-confident

Gado-not confident, Pro-not assessable

Gado-confident, Pro-not confident

Gado-confident, Pro-confident

Gado-confident, Pro-not assessable

Gado-not assessable, Pro-not confident

Gado-not assessable, Pro-confident

Gado-not assessable, Pro-not assessable

Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)

Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw

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 - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator

Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)

Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw

Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE

Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator

Gadobutrol was better than ProHance

ProHance was better than gadobutrol

Both image sets were comparable

Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as "confident in treatment planning" with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure

Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE

Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator

Gadobutrol was better: newly detected lesions

Gadobutrol was better: lesion size exceeds limit

Gadobutrol better: newly treatable lesions

Gadobutrol was better: extended radiation area

Gadobutrol was better: clarified radiation area

ProHance was better: newly detected lesions

ProHance was better: lesion size exceeds the limit

ProHance was better: newly treatable lesions

ProHance was better: extended radiation area

ProHance was better: clarified radiation area

Number of Participants With Reasons for Performance in SRS Planning by TPE

Gadobutrol was better: other

ProHance was better: other

Number of Participants With Reasons for Performance in SRS Planning by Investigator

Lesion Size Evaluated by Independent Radiologist

Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist

Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions

Participants who received two injections of gadobutrol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadoteridol 0.1 mmol/kg bw in Period 2

Gadobutrol Then Gadoteridol

Participants who received two injections of gadoteridol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadobutrol 0.1 mmol/kg bw in Period 2

Spots Global Cancer Trial Database for SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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