SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study
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ClinicalTrials.gov Identifier: NCT00522951 |
Recruitment Status :
Completed
First Posted : August 30, 2007
Results First Posted : August 3, 2011
Last Update Posted : August 28, 2017
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Condition or disease | Intervention/treatment | Phase |
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Brain Metastases | Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875) Drug: ProHance | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 165 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Diagnostic |
Official Title: | 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 |
Study Start Date : | August 2007 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | August 2008 |

Arm | Intervention/treatment |
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Experimental: Gadobutrol 0.1 mmol/kg bw
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
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Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Gadobutrol enhanced MRI (first injection of gadobutrol 0.1 mmol/kg bw, corresponding to a dose of 0.1 mmol/kg bw) |
Experimental: Gadobutrol 0.2 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
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Drug: 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) |
Experimental: Gadoteridol (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
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Drug: ProHance
ProHance enhanced MRI (two injections of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw) |
- Number of Lesions Detected by Blinded Readers (BR) and Investigator [ Time Frame: one day ]Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator
- Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader [ Time Frame: 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 - Degree of Lesion Contrast Enhancement by Investigator [ Time Frame: 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 Blinded Reader [ Time Frame: 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)
- Score of Visibility Assessment - Border Delineation by Investigator [ Time Frame: 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) [ Time Frame: 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 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator [ Time Frame: 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 [ Time Frame: 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)
- Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator [ Time Frame: 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)
- Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE [ Time Frame: one day ]Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by TPE
- Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator [ Time Frame: one day ]Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator
- Number of Participants With Reasons for Performance in SRS Planning by TPE [ Time Frame: 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 Reasons for Performance in SRS Planning by Investigator [ Time Frame: one day ]Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)
- Lesion Size Evaluated by Independent Radiologist [ Time Frame: one day ]Size of each lesion on postcontrast MR images evaluated by independent radiologist (mean and standard deviation of 603 lesions)
- Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist [ Time Frame: 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 [ Time Frame: 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.

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522951
Japan | |
Nagoya, Aichi, Japan, 464-0021 | |
Matsuyama, Ehime, Japan, 791-0280 | |
Kitakyushu, Fukuoka, Japan, 807-8555 | |
Sapporo, Hokkaido, Japan, 060-8570 | |
Kobe, Hyogo, Japan, 650-0047 | |
Sagamihara, Kanagawa, Japan, 228-8555 | |
Yokohama, Kanagawa, Japan, 222-0036 | |
Habikino, Osaka, Japan, 583-0852 | |
Habikino, Osaka, Japan, 583-8588 | |
Osakasayama, Osaka, Japan, 589-8511 | |
Hamamatsu, Shizuoka, Japan, 430-8558 | |
Sunto, Shizuoka, Japan, 411-8777 | |
Bunkyo-ku, Tokyo, Japan, 113-8431 | |
Bunkyo-ku, Tokyo, Japan, 113-8655 | |
Chuo-ku, Tokyo, Japan, 104-0045 | |
Mitaka, Tokyo, Japan, 181-8611 | |
Shinagawa-ku, Tokyo, Japan, 141-0022 | |
Yonago, Tottori, Japan, 683-8504 | |
Fukuoka, Japan, 812-8582 | |
Osaka, Japan, 558-8558 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT00522951 |
Other Study ID Numbers: |
91569 310864 ( Other Identifier: Company internal ) |
First Posted: | August 30, 2007 Key Record Dates |
Results First Posted: | August 3, 2011 |
Last Update Posted: | August 28, 2017 |
Last Verified: | July 2017 |
MRI Brain Metastasis Gadolinium Imaging Diagnostic Agent |
Neoplasm Metastasis Brain Neoplasms Neoplastic Processes Neoplasms Pathologic Processes Central Nervous System Neoplasms |
Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |