Clinical trial NCT00522951: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Brain Metastases
Keywords: MRI
Brain Metastasis
Gadolinium
Imaging
Diagnostic Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-08-30
Enrollment: 165
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Number of Lesions Detected by Blinded Readers (BR) and Investigator
timeFrame: one day
Secondary outcomes:
measure: Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader
timeFrame: one day
measure: Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator
timeFrame: one day
measure: Score of Visibility Assessment - Border Delineation by Blinded Reader
timeFrame: one day
measure: Score of Visibility Assessment - Border Delineation by Investigator
timeFrame: one day
measure: Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE)
timeFrame: one day
measure: Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator
timeFrame: one day
measure: Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE
timeFrame: one day
measure: Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator
timeFrame: one day
measure: Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE
timeFrame: one day
measure: Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator
timeFrame: one day
measure: Number of Participants With Reasons for Performance in SRS Planning by TPE
timeFrame: one day
measure: Number of Participants With Reasons for Performance in SRS Planning by Investigator
timeFrame: one day
measure: Lesion Size Evaluated by Independent Radiologist
timeFrame: one day
measure: Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist
timeFrame: one day
measure: Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions
timeFrame: one day
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Matsuyama
country: Japan
state: Ehime
city: Kitakyushu
country: Japan
state: Fukuoka
city: Sapporo
country: Japan
state: Hokkaido
city: Kobe
country: Japan
state: Hyogo
city: Sagamihara
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Habikino
country: Japan
state: Osaka
city: Habikino
country: Japan
state: Osaka
city: Osakasayama
country: Japan
state: Osaka
city: Hamamatsu
country: Japan
state: Shizuoka
city: Sunto
country: Japan
state: Shizuoka
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Chuo-ku
country: Japan
state: Tokyo
city: Mitaka
country: Japan
state: Tokyo
city: Shinagawa-ku
country: Japan
state: Tokyo
city: Yonago
country: Japan
state: Tottori
city: Fukuoka
country: Japan
city: Osaka
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
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.