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TRACER RGD-K5 Carotid Plaque Imaging Study (TRACER)

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ClinicalTrials.gov Identifier: NCT01968226
Recruitment Status : Terminated (Investigator left instititution)
First Posted : October 23, 2013
Results First Posted : August 10, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Carotid Artery Disease
Carotid Stenosis
Intervention Drug: [F-18] RDG-K5
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PET Imaging With [F-18] RDG-K5
Hide Arm/Group Description

This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging.

[F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5

Period Title: Overall Study
Started 3
Completed 1
Not Completed 2
Reason Not Completed
[F-18] RDG-K5 was not available             2
Arm/Group Title PET Imaging With [F-18] RDG-K5
Hide Arm/Group Description

This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging.

[F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
Due to trial termination, no subject analysis was completed
Age, Categorical   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
<=18 years 0
Between 18 and 65 years 0
>=65 years 0
[1]
Measure Description: No subject data analyzed
[2]
Measure Analysis Population Description: Study terminated, no subject data analyzed
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
3
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
3
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Target to Background Ratio (TBR)
Hide Description To assess uptake of [F-18]RGD-K5 by carotid plaque with PET/CT imaging (which will be expressed as a target to background ratio (TBR) of the standard uptake value (SUV)) in participants prior to carotid endarterectomy. The TBR of [F-18]RGD-K5 in the plaque will serve as a surrogate marker of plaque inflammation in participants being considered for carotid endarterectomy.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
no subject analysis done
Arm/Group Title PET Imaging With [F-18] RDG-K5
Hide Arm/Group Description:

This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging.

[F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5

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 PET Imaging With [F-18] RDG-K5
Hide Arm/Group Description

This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging.

[F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5

All-Cause Mortality
PET Imaging With [F-18] RDG-K5
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PET Imaging With [F-18] RDG-K5
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PET Imaging With [F-18] RDG-K5
Affected / at Risk (%)
Total   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Balaji Tamarappoo
Organization: Cleveland Clinic
Phone: 216-444-6765
EMail: tamarab@ccf.org
Layout table for additonal information
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01968226     History of Changes
Other Study ID Numbers: K5 IND
First Submitted: October 17, 2013
First Posted: October 23, 2013
Results First Submitted: July 13, 2017
Results First Posted: August 10, 2017
Last Update Posted: September 12, 2017