[F-18] RGD-K5 Positron Emission Tomography (PET) in Participants With Carotid Artery Stenosis
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|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|
- To assess the uptake of [F-18]RDG-K5 by carotid plaque with Positron Emission Tomography. [ Time Frame: Participants will be followed for an average of 6 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
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
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).
|Contact: Arkadij Elizarov||310-846 firstname.lastname@example.org|
|Contact: Ashok G Chaudhary||215-699 email@example.com|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Claire Parker 216-445-6821 firstname.lastname@example.org|
|Contact: Suzanne Fleming 216-444-2521 email@example.com|
|Principal Investigator: Balaji Tamarappoo, MD, PhD|
|Principal Investigator:||Balaji Tamarappoo, MD, PhD||The Cleveland Clinic|
|Study Director:||Edward Aten, MD||President, Certus International|