MedDataX Logo

Trial Outcomes & Findings for TRACER RGD-K5 Carotid Plaque Imaging Study (NCT NCT01968226)

NCT ID: NCT01968226

Last Updated: 2017-09-12

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Baseline

Results posted on

2017-09-12

Participant Flow

Participant milestones

Participant milestones
Measure
PET Imaging With [F-18] RDG-K5
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 Study
STARTED
3
Overall Study
COMPLETED
1
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Reasons for withdrawal
Measure
PET Imaging With [F-18] RDG-K5
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 Study
[F-18] RDG-K5 was not available
2

Baseline Characteristics

Study terminated, no subject data analyzed

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
PET Imaging With [F-18] RDG-K5
n=3 Participants
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
Age, Categorical
<=18 years
0 Participants
Study terminated, no subject data analyzed
Age, Categorical
Between 18 and 65 years
0 Participants
Study terminated, no subject data analyzed
Age, Categorical
>=65 years
0 Participants
Study terminated, no subject data analyzed
Sex: Female, Male
Female
1 Participants
n=3 Participants
Sex: Female, Male
Male
2 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=3 Participants
Race (NIH/OMB)
Asian
0 Participants
n=3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=3 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=3 Participants
Race (NIH/OMB)
White
3 Participants
n=3 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=3 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=3 Participants

PRIMARY outcome

Timeframe: Baseline

Population: no subject analysis done

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.

Outcome measures

Outcome data not reported

Adverse Events

PET Imaging With [F-18] RDG-K5

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Balaji Tamarappoo

Cleveland Clinic

Phone: 216-444-6765

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place