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

Brain Metastases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522951
• Other study ID #: 91569
• Secondary ID: 310864
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2007
• Last updated: October 22, 2013
• Start date: August 2007
• Est. completion date: August 2008

Study information

• Verified date: October 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

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)
• 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)
• ProHance
ProHance enhanced MRI (two injections of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)

Locations

Country	Name	City	State
Japan	Juntendo University Juntendo Hospital	Bunkyo-ku	Tokyo
Japan	University of Tokyo Hospital	Bunkyo-ku	Tokyo
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	Kyushu University Hospital	Fukuoka
Japan	Osaka Pre. Medical Center for Resp. and Allergic Diseases	Habikino	Osaka
Japan	Shiroyama Hospital	Habikino	Osaka
Japan	Seirei Hamamatsu General Hospital	Hamamatsu	Shizuoka
Japan	University of Occupational and Environmental Health	Kitakyushu	Fukuoka
Japan	Institute of Biomedical Research and Innovation	Kobe	Hyogo
Japan	Shikoku Cancer Center	Matsuyama	Ehime
Japan	Kyorin University Hospital	Mitaka	Tokyo
Japan	Aichi Cancer Center Hospital	Nagoya	Aichi
Japan	Osaka General Medical Center	Osaka
Japan	Kinki University Hospital	Osakasayama	Osaka
Japan	Kitasato University Hospital	Sagamihara	Kanagawa
Japan	Nakamura Memorial Hospital	Sapporo	Hokkaido
Japan	NTT Medical Center Tokyo	Shinagawa-ku	Tokyo
Japan	Shizuoka Cancer Center	Sunto	Shizuoka
Japan	Yokohama Rosai Hospital	Yokohama	Kanagawa
Japan	Tottori University Hospital	Yonago	Tottori

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one day	No
Secondary	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)	one day	No
Secondary	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)	one day	No
Secondary	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)	one day	No
Secondary	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)	one day	No
Secondary	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)	one day	No
Secondary	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)	one day	No
Secondary	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)	one day	No
Secondary	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)	one day	No
Secondary	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	one day	No
Secondary	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	one day	No
Secondary	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)	one day	No
Secondary	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)	one day	No
Secondary	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)	one day	No
Secondary	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)	one day	No
Secondary	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.	one day	No

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