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[F-18] RGD-K5 Positron Emission Tomography (PET) in Participants With Carotid Artery Stenosis

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ClinicalTrials.gov Identifier: NCT01602471
Recruitment Status : Terminated (Sponsor decided to develop the product in collaboration)
First Posted : May 21, 2012
Results First Posted : September 27, 2013
Last Update Posted : September 27, 2013
Sponsor:
Information provided by (Responsible Party):
Siemens Molecular Imaging

Tracking Information
First Submitted Date  ICMJE September 14, 2011
First Posted Date  ICMJE May 21, 2012
Results First Submitted Date  ICMJE July 26, 2013
Results First Posted Date  ICMJE September 27, 2013
Last Update Posted Date September 27, 2013
Study Start Date  ICMJE May 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2013)
[F-18]RDG-K5 Uptake by Carotid Plaque on PET Scan [ Time Frame: Participants will be followed for an average of 6 weeks ]
Based on the small sample size and lack of IHC analyses, no efficacy conclusions can be drawn from this study.
Original Primary Outcome Measures  ICMJE
 (submitted: May 17, 2012)
  • To assess if RGD-K5 uptake is visualized in carotid plaque by Positron Emission Tomography. [ Time Frame: Participants will be followed for an average of 6 weeks ]
  • To collect safety data of [F-18]RGD-K5 in participants with carotid atherosclerosis. [ Time Frame: safety data will be collected for an average of 3 weeks ]
Change History Complete list of historical versions of study NCT01602471 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE [F-18] RGD-K5 Positron Emission Tomography (PET) in Participants With Carotid Artery Stenosis
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 This trial will be the first trial for the Investigation Product (IP), [F-18]RGD-K5 for carotid plaque imaging and will be conducted as a Phase II trial since this compound has already been tested in humans for phase I and phase II imaging. All study results will be evaluated and analyzed in order to consider the design for future clinical trials.
Detailed Description

This investigation will be conducted as a Phase II, open-label, single-center, non-randomized study. The study is planned to be conducted at one Investigative site in the United States. The information collected under this exploratory, Phase II study will not be used for diagnostic purposes, to assess the participant's response to therapy, or for clinical management of the participant. This will be a pilot prospective cohort study where the increased expression of integrin may be seen on the F-18 RGD-K5 PET imaging scans looking at carotid plaque in participants with carotid artery stenosis.

Each completed study participant will undergo one to three visits, including one eligibility study visit, the Computed Tomography (CT) angiogram of the carotid visit (if necessary), the [F-18] RGD-K5 PET imaging visit, and a 24 hour follow up phone call or visit.

Procedures: Informed consent (ICF), eligibility blood labs, collection of demographic information and medical history, physical examination, vital signs, 12-lead Electrocardiograms (ECGs), dosing with [F-18]RGD-K5, PET imaging scan, 24 hour follow up to collect adverse events, and plaque immunohistochemical characterization after Carotid Endarterectomy (CEA).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Carotid Stenosis
Intervention  ICMJE Drug: [F-18]RDG-K5
Approximately fifteen (15) patients with carotid artery stenosis > 69% will undergo an endarterectomy and will be imaged under PET/CT with [F-18]RGD-K5
Other Names:
  • RGD-K5
  • K5
  • [F-18]RGD-K5 PET scan
  • RGD-K5 PET scan
  • K5 PET scan
Study Arms  ICMJE Experimental: [F-18]RDG-K5
[F-18]RDG-K5 was administred and PET scan performed
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: July 26, 2013)
5
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2012)
15
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (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 >69% luminal diameter as based on carotid ultrasound and who is deemed to be a surgical candidate for endarterectomy as determined by the vascular surgeon
  • Participant has had a carotid ultrasound and the report is available for collection
  • Participant has had or is scheduled to have a carotid CT angiogram for plaque localization within 30 days of signing ICF (or else scheduled Carotid CT angiogram) 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 function 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:

  • Participant is nursing
  • 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 NCT01602471
Other Study ID Numbers  ICMJE K5-C200
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Siemens Molecular Imaging
Study Sponsor  ICMJE Siemens Molecular Imaging
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Balaji Tamarappoo, MD, PhD The Cleveland Clinic
Study Director: Edward Aten, MD President, Certus International
PRS Account Siemens Molecular Imaging
Verification Date July 2013

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