[F-18] RGD-K5 Positron Emission Tomography (PET) in Participants With Carotid Artery Stenosis
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ClinicalTrials.gov Identifier: NCT01602471 |
Recruitment Status :
Terminated
(Sponsor decided to develop the product in collaboration)
First Posted : May 21, 2012
Results First Posted : September 27, 2013
Last Update Posted : September 27, 2013
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Sponsor:
Siemens Molecular Imaging
Information provided by (Responsible Party):
Siemens Molecular Imaging
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label) |
Condition |
Carotid Stenosis |
Intervention |
Drug: [F-18]RDG-K5 |
Enrollment | 5 |
Participant Flow
Recruitment Details | Five participants enrolled, four complete and one withdrawal prior to receiving the investigational product. Study was terminated early by the sponsor. |
Pre-assignment Details |
Arm/Group Title | [F-18]RDG-K5 |
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[F-18]RDG-K5 was administred and PET scan performed |
Period Title: Overall Study | |
Started | 4 |
Completed | 4 |
Not Completed | 0 |
Baseline Characteristics
Arm/Group Title | [F-18]RDG-K5 | |
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[F-18]RDG-K5 was administred and PET scan performed | |
Overall Number of Baseline Participants | 4 | |
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Five participants enrolled, four complete and one withdrawal prior to receiving the investigational prodcut. Study was terminated early by the sponsor.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 4 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
2 50.0%
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>=65 years |
2 50.0%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 4 participants | |
70.8 (10.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 4 participants | |
Female |
0 0.0%
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Male |
4 100.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 4 participants |
4 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Edward M. Aten, M.D. |
Organization: | Certus International, Inc. |
Phone: | 603.627.1212 |
EMail: | eaten@certusintl.com |
Responsible Party: | Siemens Molecular Imaging |
ClinicalTrials.gov Identifier: | NCT01602471 |
Other Study ID Numbers: |
K5-C200 |
First Submitted: | September 14, 2011 |
First Posted: | May 21, 2012 |
Results First Submitted: | July 26, 2013 |
Results First Posted: | September 27, 2013 |
Last Update Posted: | September 27, 2013 |