Trial Outcomes & Findings for TRACER [F-18] RDG-K5 Carotid Plaque Imaging Study (NCT NCT03364270)

Last Updated: 2022-08-09

Results Overview

To assess the uptake of \[F-18\] RGD-K5 by carotid plaque with PET/MRI imaging in participants prior to carotid enterectomy and thereby determine if carotid plaque that causes TIA or stroke symptoms is characterized by increased integrin expression and enhanced angiogenesis. Each patient serves as their own control. \[F-18\] RGD-K5 (radiotracer) uptake is measured (expressed as target to background ratio) in the carotid artery containing the plaque considered responsible for causing stroke or TIA symptoms (culprit plaque). Plaque maximum standardized uptake value (RT SUVmax) of the radiotracer is compared to tracer maximum standardized uptake value (RT SUVmax) in the contralateral carotid artery which does not contain cluprit plaque.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

within 96 hrs of a stroke or TIA (transient ischemic attack)

Results posted on

2022-08-09

Participant Flow

Patients were recruited from outpatient clinic or from the hospital.

Participant milestones

Participant milestones
Measure	Patients With Carotid Atherosclerosis Patients deemed to have carotid artery plaque and with symptoms of stroke or transient ischemic attack or those with significant atherosclerosis defined as \>70%.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TRACER [F-18] RDG-K5 Carotid Plaque Imaging Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Carotid Atherosclerosis n=6 Participants Patients deemed to have carotid artery plaque who had previously experienced symptoms of stroke or transient ischemic attack or those with significant atherosclerosis defined as \>70%.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: within 96 hrs of a stroke or TIA (transient ischemic attack)

Population: We enrolled and imaged with PET-MRI, 6 patients with carotid atherosclerosis. Carotid plaque was imaged 2h post injection of 10-12.5mCi of 18F-RGD peptide. 18F-RGD uptake by atherosclerotic plaque was quantified in the culprit artery implicated in stroke or transient ischemic attack and was compared to 18F-RGD uptake in the contralateral carotid artery.

Outcome measures

Outcome measures
Measure	Arm: Stroke/TIA n=6 plaque Atherosclerotic plaque in the artery implicated in causing stroke or TIA symptoms.	Arm: Non-Stroke/TIA n=6 plaque 18F-RGD uptake by atherosclerotic plaque in the contralateral artery not implicated in stroke or TIA
Uptake of [F-18] RGD-K5 by Carotid Plaque With PET/MRI Imaging in the Artery Believed to be the Cause of Transient Ischemic Attack (TIA) or Stroke Symptoms Compared to the Contralateral Carotid Artery Not Implicated in TIA or Stroke	1.78 Ratio SUV max Standard Deviation 0.21	1.2 Ratio SUV max Standard Deviation 0.15

SECONDARY outcome

Timeframe: at the time of imaging and immediately following imaging

To determine if there were any adverse events in patients who underwent PET/MRI imaging with \[F-18\] RGD-K5. We documented and reported the percent of individuals who experienced significant adverse events.

Outcome measures

Outcome measures
Measure	Arm: Stroke/TIA n=6 Participants Atherosclerotic plaque in the artery implicated in causing stroke or TIA symptoms.	Arm: Non-Stroke/TIA 18F-RGD uptake by atherosclerotic plaque in the contralateral artery not implicated in stroke or TIA
Number of Participants With Carotid Atherosclerosis	0 Participants	—

Adverse Events

[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

Balaji Tamarappoo, MD

Cedars-Sinai Medical Center

Phone: 3104232219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place