SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study
This study has been completed.
Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00522951
First received: August 29, 2007
Last updated: October 22, 2013
Last verified: October 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Metastases |
Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875) Drug: ProHance |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) 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 |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Number of Lesions Detected by Blinded Readers (BR) and Investigator [ Time Frame: one day ] [ Designated as safety issue: No ]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:
- Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader [ Time Frame: one day ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 165 |
| Study Start Date: | August 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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
|
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
|
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)
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522951
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522951
Locations
| Japan | |
| Aichi Cancer Center Hospital | |
| Nagoya, Aichi, Japan, 464-0021 | |
| Shikoku Cancer Center | |
| Matsuyama, Ehime, Japan, 791-0280 | |
| University of Occupational and Environmental Health | |
| Kitakyushu, Fukuoka, Japan, 807-8555 | |
| Nakamura Memorial Hospital | |
| Sapporo, Hokkaido, Japan, 060-8570 | |
| Institute of Biomedical Research and Innovation | |
| Kobe, Hyogo, Japan, 650-0047 | |
| Kitasato University Hospital | |
| Sagamihara, Kanagawa, Japan, 228-8555 | |
| Yokohama Rosai Hospital | |
| Yokohama, Kanagawa, Japan, 222-0036 | |
| Osaka Pre. Medical Center for Resp. and Allergic Diseases | |
| Habikino, Osaka, Japan, 583-8588 | |
| Shiroyama Hospital | |
| Habikino, Osaka, Japan, 583-0852 | |
| Kinki University Hospital | |
| Osakasayama, Osaka, Japan, 589-8511 | |
| Seirei Hamamatsu General Hospital | |
| Hamamatsu, Shizuoka, Japan, 430-8558 | |
| Shizuoka Cancer Center | |
| Sunto, Shizuoka, Japan, 411-8777 | |
| Juntendo University Juntendo Hospital | |
| Bunkyo-ku, Tokyo, Japan, 113-8431 | |
| University of Tokyo Hospital | |
| Bunkyo-ku, Tokyo, Japan, 113-8655 | |
| National Cancer Center Hospital | |
| Chuo-ku, Tokyo, Japan, 104-0045 | |
| Kyorin University Hospital | |
| Mitaka, Tokyo, Japan, 181-8611 | |
| NTT Medical Center Tokyo | |
| Shinagawa-ku, Tokyo, Japan, 141-0022 | |
| Tottori University Hospital | |
| Yonago, Tottori, Japan, 683-8504 | |
| Kyushu University Hospital | |
| Fukuoka, Japan, 812-8582 | |
| Osaka General Medical Center | |
| Osaka, Japan, 558-8558 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
Publications:
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00522951 History of Changes |
| Other Study ID Numbers: | 91569, 310864 |
| Study First Received: | August 29, 2007 |
| Results First Received: | July 5, 2011 |
| Last Updated: | October 22, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Bayer:
|
MRI Brain Metastasis Gadolinium Imaging Diagnostic Agent |
Additional relevant MeSH terms:
|
Gadobutrol Gadoteridol Contrast Media Diagnostic Uses of Chemicals Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 03, 2015