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[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
Sponsor:
Information provided by (Responsible Party):
Siemens Molecular Imaging

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Carotid Stenosis
Intervention Drug: [F-18]RDG-K5
Enrollment 5
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
Hide Arm/Group Description [F-18]RDG-K5 was administred and PET scan performed
Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title [F-18]RDG-K5
Hide Arm/Group Description [F-18]RDG-K5 was administred and PET scan performed
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
Five participants enrolled, four complete and one withdrawal prior to receiving the investigational prodcut. Study was terminated early by the sponsor.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  50.0%
>=65 years
2
  50.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
70.8  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
0
   0.0%
Male
4
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title [F-18]RDG-K5 Uptake by Carotid Plaque on PET Scan
Hide Description Based on the small sample size and lack of IHC analyses, no efficacy conclusions can be drawn from this study.
Time Frame Participants will be followed for an average of 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title [F-18]RDG-K5
Hide Arm/Group Description:
[F-18]RDG-K5 was administred and PET scan performed
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title [F-18]RDG-K5
Hide Arm/Group Description [F-18]RDG-K5 was administred and PET scan performed
All-Cause Mortality
[F-18]RDG-K5
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
[F-18]RDG-K5
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
[F-18]RDG-K5
Affected / at Risk (%)
Total   0/4 (0.00%) 
[Not Specified]
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: Edward M. Aten, M.D.
Organization: Certus International, Inc.
Phone: 603.627.1212
Responsible Party: Siemens Molecular Imaging
ClinicalTrials.gov Identifier: NCT01602471     History of Changes
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