NCT01602471

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Siemens Molecular Imaging · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Carotid Stenosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-05-21
• Last updated: 2013-09-27
• Results posted: 2013-09-27

Locations

1 site across 1 country: United States