TRACER RGD-K5 Carotid Plaque Imaging Study



Status:Terminated
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/11/2017
Start Date:November 2013
End Date:June 2016

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An Exploratory, Phase II, Open Label, Single-Center, Non-Randomized Study Of [F-18] RGD-K5 Positron Emission Tomography (PET) In Participants With Carotid Artery Stenosis

The purpose of this study is to investigate the ability of the compound[F-18]RGD-K5, when
used as a tracer during PET (positron emission tomography) imaging, to detect regions of
unstable atherosclerotic plaque in the carotid artery of subjects being considered for
carotid endarterectomy (CEA),and to confirm this ability through histological studies of
samples of carotid artery plaques that will be collected during the planned carotid surgery.

Patients will be chosen for the study based on presence of carotid artery stenosis
ascertained by CTA and carotid artery ultrasound. Patients will receive and intravenous
injection of the radiolabeled PET tracer,[F-18]RGD-K5, and will undergo PET imaging of their
carotid arteries bilaterally. PET images will be analyzed to determine the standard uptake
value (SUV) of [F-18]RGD-K5 uptake by the carotid artery plaque and this will be compared to
the SUV of the background (blood pool in the aorta). This will be expressed as a target to
background ratio (TBR). Investigators expect to find a significant uptake of [F-18]RGD-K5 by
carotid artery palque and investigators therefore expect to find a TBR that is significantly
>1. Investigators also expect to find that plaque from patients who show a TBR >1 will also
be enriched for histologic markers for inflammation and angiogenesis.

Inclusion Criteria:

- Participant is a female or male of any race/ethnicity >18 years old at the time of
the investigational product administration

- Participant or participant's legally acceptable representative provides written
informed consent

- Participant is capable of complying with study procedures

- Participant has known carotid artery stenosis of >50% luminal diameter based on
carotid ultrasound or computed tomography angiography (CTA), as stated in official
clinical report or as measured by PI if no quantitative assessment appears in the
report, and who is deemed to be a surgical candidate for endarterectomy

- Participant has had a carotid ultrasound and/or computed tomography angiography (CTA)
and the report is available for collection

- Participant has had or is scheduled to have a carotid CT angiogram for plaque
localization within 60 days of signing ICF (or else scheduled CTA must be performed
on a separate day and prior to the investigational PET procedure)

- Participant has consented to have an endarterectomy

- Participant will be scheduled for an investigational[F-18]RGD-K5 PET/CT scan within 4
weeks prior to endarterectomy

- Participant must have renal functions values as defined by laboratory results within
the following ranges:

- Serum creatinine ≤ 1.5 mg/dL

- Estimated glomerular filtration rate (eGFR): ≥ 45mL/min

Exclusion Criteria:

- Female participant is nursing

- Female participant is pregnant

- Participant has been involved in an investigative, radioactive research procedure
within the past 14 days

- Participant has any other condition or personal circumstance that, in the judgment of
the investigator, might interfere with the collection of complete data or data
quality

- Participant has a history or current evidence of any condition, therapy, lab
abnormality that, in the opinion of the study investigator or treating physicians
might confound the results of the study or poses an additional risk to the
participants by their participation in the study
We found this trial at
1
site
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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