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

Primary Purpose

Brain Metastases

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Gadobutrol (Gadavist, Gadovist, BAY86-4875)
ProHance
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Metastases focused on measuring MRI, Brain Metastasis, Gadolinium, Imaging, Diagnostic Agent

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Gadobutrol 0.1 mmol/kg bw

Gadobutrol 0.2 mmol/kg bw

Gadoteridol (ProHance)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Number of Lesions Detected by Blinded Readers (BR) and Investigator
Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator

Secondary Outcome Measures

Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
August 29, 2007
Last Updated
July 28, 2017
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00522951
Brief Title
SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
MRI, Brain Metastasis, Gadolinium, Imaging, Diagnostic Agent

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gadobutrol 0.1 mmol/kg bw
Arm Type
Experimental
Arm Description
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
Arm Title
Gadobutrol 0.2 mmol/kg bw
Arm Type
Experimental
Arm Description
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
Arm Title
Gadoteridol (ProHance)
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Intervention Description
Gadobutrol enhanced MRI (first injection of gadobutrol 0.1 mmol/kg bw, corresponding to a dose of 0.1 mmol/kg bw)
Intervention Type
Drug
Intervention Name(s)
Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Intervention Description
Gadobutrol enhanced MRI (second injection of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)
Intervention Type
Drug
Intervention Name(s)
ProHance
Intervention Description
ProHance enhanced MRI (two injections of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)
Primary Outcome Measure Information:
Title
Number of Lesions Detected by Blinded Readers (BR) and Investigator
Description
Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator
Time Frame
one day
Secondary Outcome Measure Information:
Title
Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader
Description
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)
Time Frame
one day
Title
Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator
Description
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)
Time Frame
one day
Title
Score of Visibility Assessment - Border Delineation by Blinded Reader
Description
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)
Time Frame
one day
Title
Score of Visibility Assessment - Border Delineation by Investigator
Description
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)
Time Frame
one day
Title
Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE)
Description
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)
Time Frame
one day
Title
Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator
Description
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)
Time Frame
one day
Title
Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE
Description
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)
Time Frame
one day
Title
Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator
Description
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)
Time Frame
one day
Title
Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE
Description
Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by TPE
Time Frame
one day
Title
Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator
Description
Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator
Time Frame
one day
Title
Number of Participants With Reasons for Performance in SRS Planning by TPE
Description
Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)
Time Frame
one day
Title
Number of Participants With Reasons for Performance in SRS Planning by Investigator
Description
Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)
Time Frame
one day
Title
Lesion Size Evaluated by Independent Radiologist
Description
Size of each lesion on postcontrast MR images evaluated by independent radiologist (mean and standard deviation of 603 lesions)
Time Frame
one day
Title
Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist
Description
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)
Time Frame
one day
Title
Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions
Description
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.
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-0021
Country
Japan
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
807-8555
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8570
Country
Japan
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
228-8555
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
222-0036
Country
Japan
City
Habikino
State/Province
Osaka
ZIP/Postal Code
583-0852
Country
Japan
City
Habikino
State/Province
Osaka
ZIP/Postal Code
583-8588
Country
Japan
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
430-8558
Country
Japan
City
Sunto
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-0022
Country
Japan
City
Yonago
State/Province
Tottori
ZIP/Postal Code
683-8504
Country
Japan
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
21467949
Citation
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.
Results Reference
result

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

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