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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

Tracking Information
First Submitted Date  ICMJE October 17, 2013
First Posted Date  ICMJE October 23, 2013
Results First Submitted Date  ICMJE July 13, 2017
Results First Posted Date  ICMJE August 10, 2017
Last Update Posted Date September 12, 2017
Actual Study Start Date  ICMJE November 2013
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2017)
Target to Background Ratio (TBR) [ Time Frame: Baseline ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2013)
Target to Background Ratio (TBR) [ Time Frame: at time of PET imaging ]
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.
Change History Complete list of historical versions of study NCT01968226 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2013)
Occurrence of adverse events [ Time Frame: at time of carotid endarterectomy ]
In order to document that this tracer, [F-18]RGD-K5, is safe for clinical use in plaque imaging, patients will be contacted 24h after receiving the [F-18]RGD-K5. They will be questioned about any side effects or adverse events they might have experienced during that time after receiving the tracer.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TRACER RGD-K5 Carotid Plaque Imaging Study
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Carotid Artery Disease
  • Carotid Stenosis
Intervention  ICMJE Drug: [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
Other Name: Radiolabeled tracer
Study Arms  ICMJE Experimental: 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.
Intervention: Drug: [F-18] RDG-K5
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 9, 2017)
3
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2013)
15
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01968226
Other Study ID Numbers  ICMJE K5 IND
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Balaji Tamarappoo, MD, PhD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP