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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00522951
First Posted: August 30, 2007
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
August 29, 2007
August 30, 2007
July 5, 2011
August 3, 2011
August 28, 2017
August 2007
August 2008   (Final data collection date for primary outcome measure)
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
The total number of metastatic lesions detected. [ Time Frame: 4 days ]
Complete list of historical versions of study NCT00522951 on ClinicalTrials.gov Archive Site
  • 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.
Confidence and performance in treatment planning, visibility of lesions, contrast noise ratio by signal intensity and size measurement. [ Time Frame: 4 days ]
Not Provided
Not Provided
 
SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Brain Metastases
  • 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)
  • 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
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.
 
Completed
165
August 2008
August 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00522951
91569
310864 ( Other Identifier: Company internal )
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
July 2017

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