Trial Condition(s):
Brain Metastases
SH L 562BB Phase II/III dose justification and gadoteridol-controlled comparative study
Bayer Identifier:
91569
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Sapporo, Japan, 060-8570 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bunkyo-ku, Japan, 113-8431 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shinagawa-ku, Japan, 141-0022 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yokohama, Japan, 222-0036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sagamihara, Japan, 228-8555 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamamatsu, Japan, 430-8558 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 464-0021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yonago, Japan, 683-8504 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Matsuyama, Japan, 791-0280 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kitakyushu, Japan, 807-8555 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukuoka, Japan, 812-8582 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Habikino, Japan, 583-8588 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 558-8558 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kobe, Japan, 650-0047 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bunkyo-ku, Japan, 113-8655 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chuo-ku, Japan, 104-0045 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mitaka, Japan, 181-8611 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sunto, Japan, 411-8777 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Habikino, Japan, 583-0852 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osakasayama, Japan, 589-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Number of lesions detected by blinded readers (BR) and investigatorTimeframe: one day
Secondary Outcome
- Score of visibility assessment - Degree of lesion contrast enhancement by blinded readerTimeframe: one day
- Score of visibility assessment - Degree of lesion contrast enhancement by investigatorTimeframe: one day
- Score of visibility assessment - Border delineation by blinded readerTimeframe: one day
- Score of visibility assessment - Border delineation by investigatorTimeframe: one day
- Treatment planning confidence - Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw by Treatment Planning Experts (TPE)Timeframe: one day
- Treatment planning confidence - Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw by investigatorTimeframe: one day
- Treatment planning confidence - Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw by TPETimeframe: one day
- Treatment planning confidence - Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw by investigatorTimeframe: one day
- Number of participants with performance in stereotactic radiosurgery (SRS) planning by TPETimeframe: one day
- Number of participants with performance in stereotactic radiosurgery (SRS) planning by investigatorTimeframe: one day
- Number of participants with reasons for performance in SRS planning by TPETimeframe: one day
- Number of participants with reasons for performance in SRS planning by investigatorTimeframe: one day
- Lesion size evaluated by independent radiologistTimeframe: one day
- Contrast noise ratio (CNR) of lesions evaluated by independent radiologistTimeframe: one day
- Intraclass correlation coefficient (ICC) among 3 blinded readers on the number of detected lesionsTimeframe: one day
Additional Information
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