SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00522951
First received: August 29, 2007
Last updated: October 22, 2013
Last verified: October 2013
  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

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
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: 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:
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
Gadoteridol
Gadobutrol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014