Contrast-enhanced MRI in Children 2 Months to <2 Years
2015年10月19日 更新者:Bayer
Open-label, Multi-center, Two-stage, Age Stratified, Pharmacokinetic, Safety, and Efficacy Study in Children 2 Months to < 2 Years of Age Undergoing Magnevist Injection Enhanced MRI
The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist in children 2 months to < 2 years of age
調査の概要
詳細な説明
Safety issues are addressed in the AE section
研究の種類
介入
入学 (実際)
54
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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San Diego、California、アメリカ、92123
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Colorado
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Aurora、Colorado、アメリカ、80045
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Illinois
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Chicago、Illinois、アメリカ、60614
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Iowa
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Iowa City、Iowa、アメリカ、52242
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Missouri
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Kansas City、Missouri、アメリカ、64108-9898
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St. Louis、Missouri、アメリカ、63110
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Ohio
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Akron、Ohio、アメリカ、44308
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Pennsylvania
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Hershey、Pennsylvania、アメリカ、17033
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Texas
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Houston、Texas、アメリカ、77030
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Sachsen
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Dresden、Sachsen、ドイツ、01307
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Sachsen-Anhalt
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Halle、Sachsen-Anhalt、ドイツ、06120
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Schleswig-Holstein
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Kiel、Schleswig-Holstein、ドイツ、24105
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Thüringen
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Jena、Thüringen、ドイツ、07740
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
2ヶ月~1年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Age: 2 months to < 2 years (23 months)
- Participants (male/female) who are scheduled to undergo gadolinium-enhanced MRI
- Able to comply with the study procedures
Exclusion Criteria:
- Clinical unstable participants (eg, intensive care unit)
- Renal Insufficiency
- Participants undergoing chemotherapy </= 48 hours prior to and up to 24 hours after the administration of Magnevist.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:診断
- 割り当て:非ランダム化
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Gadopentetate dimeglumine (Magnevist, BAY86-6661)
For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist.
Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
For stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
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For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist.
Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
For stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)
時間枠:Within 5 minutes after injection
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A clinical judgment by the open-label Clinical Investigators (CIs) as to whether ("yes") or not ("no") the CI could make a diagnosis from the image.
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Within 5 minutes after injection
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Dose Determined by Blinded Readers to be Superior for Diagnosis
時間枠:Within 5 minutes after injection
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Dose superiority was a calculation based upon the Blinder Readers' assessment of 4 visualization parameters
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Within 5 minutes after injection
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Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers
時間枠:Within 5 minutes after injection
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For each participant, the Blinded Reader indicated which dose had better contrast enhancement, better border delineation, clearer internal morphology, and provided more diagnostic information.
The dose chosen for 3 or 4 of these variables was the selected dose for that Reader and participant.
If each dose was superior on 2 variables, the dose which provided more diagnostic information was selected for that participant.
The dose selected for the majority of participants was the dose selected by that Reader; if chosen by 2 or 3 Readers, it was the selected dose.
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Within 5 minutes after injection
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PK Analysis - Total Clearance (CL)
時間枠:20 to 45 min and 4 to 8 hours post injection
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Total clearance is the fraction of the volume of distribution (Vd) which is completely purified per unit of time and depends also on the plasma half-life of the drug.
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20 to 45 min and 4 to 8 hours post injection
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PK Analysis - Total Clearance (CL)/Body Weight (BW)
時間枠:20 to 45 min and 4 to 8 hours post injection
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CL/BW = total clearance normalized by BW
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20 to 45 min and 4 to 8 hours post injection
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PK Analysis - Volume of Distribution at Steady State (Vss)
時間枠:20 to 45 min and 4 to 8 hours post injection
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Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.
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20 to 45 min and 4 to 8 hours post injection
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PK Analysis - Volume of Distribution at Steady State (Vss) /Body Weight (BW)
時間枠:20 to 45 min and 4 to 8 hours post injection
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Vss/BW = volume of distribution at steady state normalized by body weight
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20 to 45 min and 4 to 8 hours post injection
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PK Analysis - Area Under the Drug Concentration-time Curve (AUC)
時間枠:Samples taken 20 to 45 min and 4 to 8 hours post injection. AUC calculated from time of injection to infinity.
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AUC = Area under the drug concentration-time curve from administration to infinity
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Samples taken 20 to 45 min and 4 to 8 hours post injection. AUC calculated from time of injection to infinity.
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PK Analysis - t 1/2
時間枠:Samples taken at 20 to 45 min and at 4 to 8 hours post injection; t 1/2 calculated from area under the drug concentration-time curve from administration to infinity
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t 1/2 = termination elimination half-life calculated from the area under the drug concentration-time curve from administration to infinity
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Samples taken at 20 to 45 min and at 4 to 8 hours post injection; t 1/2 calculated from area under the drug concentration-time curve from administration to infinity
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Number of Participants With Number of Lesions Detected - Stage 1
時間枠:Within 5 minutes after injection
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BR = blinded reader; CI = clinical investigator; unenh.
image = unenhanced image; comb.
image= combined unenhanced and enhanced image.
The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions.
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Within 5 minutes after injection
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Number of Participants With Number of Lesions Detected - Stage 2
時間枠:Within 5 minutes after injection
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BR = blinded reader; CI = clinical investigator; unenh.
image = unenhanced image; comb.
image= combined unenhanced and enhanced image.
The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions.
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Within 5 minutes after injection
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Number of Participants With Quality of Lesion Visualization - Stage 1
時間枠:Within 5 minutes after injection
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BR = blinded reader; CI = clinical investigator.
The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible)
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Within 5 minutes after injection
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Number of Participants With Quality of Lesion Visualization - Stage 2
時間枠:Within 5 minutes after injection
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BR = blinded reader; CI = clinical investigator.
The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible)
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Within 5 minutes after injection
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Number of Participants With Quality of Border Delineation - Stage 1
時間枠:Within 5 minutes after injection
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BR = blinded reader; CI = clinical investigator.
The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set
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Within 5 minutes after injection
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Number of Participants With Quality of Border Delineation - Stage 2
時間枠:Within 5 minutes after injection
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BR = blinded reader; CI = clinical investigator.
The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set
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Within 5 minutes after injection
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Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1
時間枠:Within 5 minutes after injection
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BR = blinded reader; CI = clinical investigator.
The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images
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Within 5 minutes after injection
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Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2
時間枠:Within 5 minutes after injection
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BR = blinded reader; CI = clinical investigator.
The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images
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Within 5 minutes after injection
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Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1
時間枠:Within 5 minutes after injection
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The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images.
BR = blinded reader; CI = clinical investigator
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Within 5 minutes after injection
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Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2
時間枠:Within 5 minutes after injection
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The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images.
BR = blinded reader; CI = clinical investigator
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Within 5 minutes after injection
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Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1
時間枠:Within 5 minutes after injection
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Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 1.
For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators.
BR=Blinded Reader; CI=Clinical Investigator.
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Within 5 minutes after injection
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Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2
時間枠:Within 5 minutes after injection
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Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 2. For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators.
BR=Blinded Reader; CI=Clinical Investigator
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Within 5 minutes after injection
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Number of Participants With Diagnostic Confidence - Stage 1
時間枠:Within 5 minutes after injection
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The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident.
BR=Blinder Reader; CI=Clinical Investigator
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Within 5 minutes after injection
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Number of Participants With Diagnostic Confidence - Stage 2
時間枠:Within 5 minutes after injection
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The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident.
BR=Blinder Reader; CI=Clinical Investigator
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Within 5 minutes after injection
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Management Based on Unenhanced Images - Stage 1
時間枠:Within 5 minutes before injection
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For Stage 1 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.
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Within 5 minutes before injection
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Management Based on Unenhanced Images - Stage 2
時間枠:Within 5 minutes before injection
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For Stage 2 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.
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Within 5 minutes before injection
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Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1
時間枠:Within 5 minutes after injection
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For Stage 1, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for both doses.
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Within 5 minutes after injection
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Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2
時間枠:Within 5 minutes after injection
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For Stage 2, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for the optimal efficacious dose determined in Stage 1.
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Within 5 minutes after injection
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Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1
時間枠:Within 5 minutes after injection
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The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented for both doses in Stage 1
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Within 5 minutes after injection
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Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2
時間枠:Within 5 minutes after injection
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The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented in Stage 2 for the optimal efficacious dose determined in Stage 1
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Within 5 minutes after injection
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年1月1日
一次修了 (実際)
2010年9月1日
研究の完了 (実際)
2010年9月1日
試験登録日
最初に提出
2009年7月10日
QC基準を満たした最初の提出物
2009年7月10日
最初の投稿 (見積もり)
2009年7月13日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年11月18日
QC基準を満たした最後の更新が送信されました
2015年10月19日
最終確認日
2015年10月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 91784
- 2009-013081-17 (EudraCT番号)
- 312046 (その他の識別子:company internal)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
磁気共鳴画像の臨床試験
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