check_circleStudy Completed
Brain Metastases
Bayer Identifier:
91569
ClinicalTrials.gov Identifier:
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
BothAge
20 YearsTrial summary
Enrollment Goal
165Trial Dates
August 2007 - August 2008Phase
Phase 3Could I Receive a placebo
NoProducts
Gadavist/Gadovist (Gadobutrol, BAY86-4875)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 investigatordate_rangeTime Frame:one dayenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Score of visibility assessment - Degree of lesion contrast enhancement by blinded readerdate_rangeTime Frame:one dayenhanced_encryptionNoSafety Issue:
- Score of visibility assessment - Degree of lesion contrast enhancement by investigatordate_rangeTime Frame:one dayenhanced_encryptionNoSafety Issue:
- Score of visibility assessment - Border delineation by blinded readerdate_rangeTime Frame:one dayenhanced_encryptionNoSafety Issue:
- Score of visibility assessment - Border delineation by investigatordate_rangeTime Frame:one dayenhanced_encryptionNoSafety Issue:
- 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 dayenhanced_encryptionNoSafety Issue:
- Treatment planning confidence - Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw by investigatordate_rangeTime Frame:one dayenhanced_encryptionNoSafety Issue:
- Treatment planning confidence - Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw by TPEdate_rangeTime Frame:one dayenhanced_encryptionNoSafety Issue:
- Treatment planning confidence - Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw by investigatordate_rangeTime Frame:one dayenhanced_encryptionNoSafety Issue:
- Number of participants with performance in stereotactic radiosurgery (SRS) planning by TPEdate_rangeTime Frame:one dayenhanced_encryptionNoSafety Issue:
- Number of participants with performance in stereotactic radiosurgery (SRS) planning by investigatordate_rangeTime Frame:one dayenhanced_encryptionNoSafety Issue:
- Number of participants with reasons for performance in SRS planning by TPEdate_rangeTime Frame:one dayenhanced_encryptionNoSafety Issue:
- Number of participants with reasons for performance in SRS planning by investigatordate_rangeTime Frame:one dayenhanced_encryptionNoSafety Issue:
- Lesion size evaluated by independent radiologistdate_rangeTime Frame:one dayenhanced_encryptionNoSafety Issue:
- Contrast noise ratio (CNR) of lesions evaluated by independent radiologistdate_rangeTime Frame:one dayenhanced_encryptionNoSafety Issue:
- Intraclass correlation coefficient (ICC) among 3 blinded readers on the number of detected lesionsdate_rangeTime Frame:one dayenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
RandomizedBlinding
Single BlindAssignment
Crossover AssignmentTrial Arms
3