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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary:

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).


Sponsor: Siemens Molecular Imaging

Current Primary Outcome: [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:

  • 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 ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Siemens Molecular Imaging

Dates:
Date Received: September 14, 2011
Date Started: May 2012
Date Completion:
Last Updated: July 26, 2013
Last Verified: July 2013