SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00522951
First received: August 29, 2007
Last updated: October 31, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
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 | |
| Univ. HP of Occupational and Environmental Health, Japan | |
| 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 | |
| Shiroyama Hospital | |
| Habikino, Osaka, Japan, 583-0852 | |
| Osaka Pre. Medical Center for Resp. and Allergic Diseases | |
| Habikino, Osaka, Japan, 583-8588 | |
| 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: | Therapeutic Area Head, Bayer Yakuhin Ltd. |
| 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 31, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Bayer:
|
MRI Brain Metastasis Gadolinium Imaging Diagnostic Agent |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 22, 2013