Contrast-enhanced MRI in Children 2 Months to <2 Years
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
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Typ studiów
Zapisy (Rzeczywisty)
Zapisy
Faza
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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Sachsen
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Dresden, Sachsen, Niemcy, 01307
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Sachsen-Anhalt
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Halle, Sachsen-Anhalt, Niemcy, 06120
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, Niemcy, 24105
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Thüringen
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Jena, Thüringen, Niemcy, 07740
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California
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San Diego, California, Stany Zjednoczone, 92123
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Colorado
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Aurora, Colorado, Stany Zjednoczone, 80045
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60614
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Iowa
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Iowa City, Iowa, Stany Zjednoczone, 52242
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Missouri
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Kansas City, Missouri, Stany Zjednoczone, 64108-9898
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St. Louis, Missouri, Stany Zjednoczone, 63110
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Ohio
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Akron, Ohio, Stany Zjednoczone, 44308
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Pennsylvania
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Hershey, Pennsylvania, Stany Zjednoczone, 17033
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Texas
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Houston, Texas, Stany Zjednoczone, 77030
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Diagnostyczny
- Przydział: Nielosowe
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Participants With Number of Lesions Detected - Stage 1
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Sponsor
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
Ukończenie studiów (Rzeczywisty)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 91784
- 2009-013081-17 (Numer EudraCT)
- 312046 (Inny identyfikator: company internal)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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