check_circleStudy Completed

Brain Metastases

Bayer Identifier:

91569

ClinicalTrials.gov Identifier:

NCT00522951

EudraCT Number:

Not Available

EU CT Number:

Not Available
SH L 562BB Phase II/III dose justification and gadoteridol-controlled comparative study

Trial 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.

Key Participants Requirements

Sex

Both

Age

20 Years
  • - Japanese patients at least 20 years of age
    - Patients with diagnosed primary cancer
    - Patients with metastatic lesions by CT/MRI
  • - Patients who have contraindication to the MRI examinations
    - Patients who have severe renal disorder
    - Patients in extremely serious general condition

Trial summary

Enrollment Goal
165
Trial Dates
August 2007 - August 2008
Phase
Phase 3
Could I Receive a placebo
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Sapporo, 060-8570, Japan
Completed
Bunkyo-ku, 113-8431, Japan
Completed
Shinagawa-ku, 141-0022, Japan
Completed
Yokohama, 222-0036, Japan
Completed
Sagamihara, 228-8555, Japan
Completed
Hamamatsu, 430-8558, Japan
Completed
Nagoya, 464-0021, Japan
Completed
Yonago, 683-8504, Japan
Completed
Matsuyama, 791-0280, Japan
Completed
Kitakyushu, 807-8555, Japan
Completed
Fukuoka, 812-8582, Japan
Completed
Habikino, 583-8588, Japan
Completed
Osaka, 558-8558, Japan
Completed
Kobe, 650-0047, Japan
Completed
Bunkyo-ku, 113-8655, Japan
Completed
Chuo-ku, 104-0045, Japan
Completed
Mitaka, 181-8611, Japan
Completed
Sunto, 411-8777, Japan
Completed
Habikino, 583-0852, Japan
Completed
Osakasayama, 589-8511, Japan

Primary Outcome

  • Number of lesions detected by blinded readers (BR) and investigator
    date_rangeTime Frame:
    one day
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Score of visibility assessment - Degree of lesion contrast enhancement by blinded reader
    date_rangeTime Frame:
    one day
    enhanced_encryption
    Safety Issue:
    No
  • Score of visibility assessment - Degree of lesion contrast enhancement by investigator
    date_rangeTime Frame:
    one day
    enhanced_encryption
    Safety Issue:
    No
  • Score of visibility assessment - Border delineation by blinded reader
    date_rangeTime Frame:
    one day
    enhanced_encryption
    Safety Issue:
    No
  • Score of visibility assessment - Border delineation by investigator
    date_rangeTime Frame:
    one day
    enhanced_encryption
    Safety Issue:
    No
  • Treatment planning confidence - Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw by Treatment Planning Experts (TPE)
    date_rangeTime Frame:
    one day
    enhanced_encryption
    Safety Issue:
    No
  • Treatment planning confidence - Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw by investigator
    date_rangeTime Frame:
    one day
    enhanced_encryption
    Safety Issue:
    No
  • Treatment planning confidence - Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw by TPE
    date_rangeTime Frame:
    one day
    enhanced_encryption
    Safety Issue:
    No
  • Treatment planning confidence - Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw by investigator
    date_rangeTime Frame:
    one day
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with performance in stereotactic radiosurgery (SRS) planning by TPE
    date_rangeTime Frame:
    one day
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with performance in stereotactic radiosurgery (SRS) planning by investigator
    date_rangeTime Frame:
    one day
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with reasons for performance in SRS planning by TPE
    date_rangeTime Frame:
    one day
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with reasons for performance in SRS planning by investigator
    date_rangeTime Frame:
    one day
    enhanced_encryption
    Safety Issue:
    No
  • Lesion size evaluated by independent radiologist
    date_rangeTime Frame:
    one day
    enhanced_encryption
    Safety Issue:
    No
  • Contrast noise ratio (CNR) of lesions evaluated by independent radiologist
    date_rangeTime Frame:
    one day
    enhanced_encryption
    Safety Issue:
    No
  • Intraclass correlation coefficient (ICC) among 3 blinded readers on the number of detected lesions
    date_rangeTime Frame:
    one day
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Randomized
Blinding
Single Blind
Assignment
Crossover Assignment
Trial Arms
3

Additional Information

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