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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
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Brain Metastases Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875) Drug: ProHance Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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

  10. 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

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information
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Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

Publications of Results:

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00522951     History of Changes
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

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