Trial record 8 of 52 for:    Open Studies | "Carotid Stenosis"

TRACER RGD-K5 Carotid Plaque Imaging Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
Balaji Tamarappoo, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier:
NCT01968226
First received: October 17, 2013
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to investigate the abilityof 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.


Condition Intervention Phase
Carotid Artery Disease
Carotid Stenosis
Drug: [F-18] RDG-K5
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Target to background ratio (TBR) [ Time Frame: at time of PET imaging ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Occurrence of adverse events [ Time Frame: at time of carotid endarterectomy ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 15
Study Start Date: November 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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). We expect to find a significant uptake of [F-18]RGD-K5 by carotid artery palque and we therefore expect to find a TBR that is significantly >1. We also expect to find that plaque from patients who show a TBR >1 will also be enriched for histologic markers for inflammation and angiogenesis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968226

Contacts
Contact: Balaji Tamarappoo, MD, PhD 216/444-6765 tamarab@ccf.org

Locations
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Balaji Tamarappoo, MD, PhD    216-444-6765    tamarab@ccf.org   
Principal Investigator: Balaji Tamarappoo, MD, PhD         
Sponsors and Collaborators
Balaji Tamarappoo
Investigators
Principal Investigator: Balaji Tamarappoo, MD, PhD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Balaji Tamarappoo, Staff, Cardiac Imaging, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT01968226     History of Changes
Other Study ID Numbers: K5 IND
Study First Received: October 17, 2013
Last Updated: October 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
carotid artery disease
carotid stenosis
carotid endarterectomy
RDG-K5
PET imaging

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Constriction, Pathologic
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 20, 2014