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Trial record 3 of 12 for:    gadoteridol

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

Tracking Information
First Submitted Date  ICMJE August 29, 2007
First Posted Date  ICMJE August 30, 2007
Results First Submitted Date  ICMJE July 5, 2011
Results First Posted Date  ICMJE August 3, 2011
Last Update Posted Date August 28, 2017
Study Start Date  ICMJE August 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2011)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2007)
The total number of metastatic lesions detected. [ Time Frame: 4 days ]
Change History Complete list of historical versions of study NCT00522951 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2007)
Confidence and performance in treatment planning, visibility of lesions, contrast noise ratio by signal intensity and size measurement. [ Time Frame: 4 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE Brain Metastases
Intervention  ICMJE
  • 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)
  • 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)
  • 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)
Study Arms  ICMJE
  • 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
    Intervention: Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
  • 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
    Intervention: Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
  • 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
    Intervention: Drug: ProHance
Publications * Katakami N, Inaba Y, Sugata S, Tsurusaki M, Itoh T, Machida T, Tanaka H, Nakayama T, Morikawa T, Breuer J, Aitoku Y. Magnetic resonance evaluation of brain metastases from systemic malignances with two doses of gadobutrol 1.0 m compared with gadoteridol: a multicenter, phase ii/iii study in patients with known or suspected brain metastases. Invest Radiol. 2011 Jul;46(7):411-8. doi: 10.1097/RLI.0b013e3182145a6c.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2012)
165
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2007)
160
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00522951
Other Study ID Numbers  ICMJE 91569
310864 ( Other Identifier: Company internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP