- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00937391
Contrast-enhanced MRI in Children 2 Months to <2 Years
2015년 10월 19일 업데이트: 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
연구 개요
상세 설명
Safety issues are addressed in the AE section
연구 유형
중재적
등록 (실제)
54
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Sachsen
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Dresden, Sachsen, 독일, 01307
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Sachsen-Anhalt
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Halle, Sachsen-Anhalt, 독일, 06120
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, 독일, 24105
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Thüringen
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Jena, Thüringen, 독일, 07740
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California
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San Diego, California, 미국, 92123
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Colorado
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Aurora, Colorado, 미국, 80045
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Illinois
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Chicago, Illinois, 미국, 60614
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Iowa
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Iowa City, Iowa, 미국, 52242
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Missouri
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Kansas City, Missouri, 미국, 64108-9898
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St. Louis, Missouri, 미국, 63110
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Ohio
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Akron, Ohio, 미국, 44308
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Pennsylvania
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Hershey, Pennsylvania, 미국, 17033
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Texas
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Houston, Texas, 미국, 77030
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
2개월 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Participants With Number of Lesions Detected - Stage 1
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 1월 1일
기본 완료 (실제)
2010년 9월 1일
연구 완료 (실제)
2010년 9월 1일
연구 등록 날짜
최초 제출
2009년 7월 10일
QC 기준을 충족하는 최초 제출
2009년 7월 10일
처음 게시됨 (추정)
2009년 7월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 11월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 10월 19일
마지막으로 확인됨
2015년 10월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 91784
- 2009-013081-17 (EudraCT 번호)
- 312046 (기타 식별자: company internal)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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Biotronik SE & Co. KG완전한
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Samsung Medical Center모집하지 않고 적극적으로
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University Hospital, Grenoble완전한관절만곡증 Amyoplasia 또는 원위 관절만곡증의 진단 | National Reference Center의 AMC Clinic에서 5일 다학제 평가 | Grenoble Alpes 병원의 Physical Medecin, Medical Genetic and Imaging 부서와 함께프랑스
Gadopentetate dimeglumine (Magnevist, BAY86-6661)에 대한 임상 시험
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The Affiliated Hospital of Qingdao University모병