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Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants

This study has been completed.
Sponsor:
Collaborator:
Lantheus Medical Imaging
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01431300
First received: September 7, 2011
Last updated: October 20, 2013
Last verified: August 2013
Results First Received: August 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Diagnostic
Condition: Healthy
Intervention: Drug: gadofosveset

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
0.01 mmol/kg of Gadofosveset Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition
0.02 mmol/kg of Gadofosveset Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition
0.03 mmol/kg of Gadofosveset Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition. This is the FDA-approved dose for lower extremity arterial imaging

Participant Flow:   Overall Study
    0.01 mmol/kg of Gadofosveset     0.02 mmol/kg of Gadofosveset     0.03 mmol/kg of Gadofosveset  
STARTED     11 [1]   10     10  
COMPLETED     10     10     10  
NOT COMPLETED     1     0     0  
[1] One subject with indeterminate pregnancy test, subject declined to proceed



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
0.01 mmol/kg gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
0.02 mmol/kg gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
0.03 mmol/kg

FDA-approved dose for lower extremity arterial imaging

gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent

Total Total of all reporting groups

Baseline Measures
    0.01 mmol/kg     0.02 mmol/kg     0.03 mmol/kg     Total  
Number of Participants  
[units: participants]
  11     10     10     31  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     11     10     10     31  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  22.2  ± 5.3     24.6  ± 8.1     24.1  ± 7.5     23.4  ± 6.8  
Gender  
[units: participants]
       
Female     1     6     1     8  
Male     10     4     9     23  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Imaging Quality Score   [ Time Frame: 14 weeks ]

2.  Secondary:   Quantitative Analysis Noise Ratios   [ Time Frame: 14 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Charles Kim
Organization: Duke University Medical Center
phone: 919-684-7284
e-mail: charles.kim@duke.edu


No publications provided by Duke University

Publications automatically indexed to this study:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01431300     History of Changes
Other Study ID Numbers: Pro00022334, CG 10011
Study First Received: September 7, 2011
Results First Received: August 1, 2013
Last Updated: October 20, 2013
Health Authority: United States: Institutional Review Board