[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

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 Overview

• Status: Terminated
• Conditions: Carotid Stenosis
• Intervention / Treatment: Drug: [F-18]RDG-K5

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: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [F-18]RDG-K5; [F-18]RDG-K5 was administred and PET scan performed	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
[F-18]RDG-K5 Uptake by Carotid Plaque on PET Scan	Based on the small sample size and lack of IHC analyses, no efficacy conclusions can be drawn from this study.	Participants will be followed for an average of 6 weeks

Collaborators and Investigators

• Sponsor: Siemens Molecular Imaging
• Investigators: Principal Investigator: Balaji Tamarappoo, MD, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: September 14, 2011
• First Submitted That Met QC Criteria: May 17, 2012
• First Posted (Estimate): May 21, 2012

Study Record Updates

• Last Update Posted (Estimate): September 27, 2013
• Last Update Submitted That Met QC Criteria: July 26, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Endarterectomy; K5-C200; RGD-K5; angiogenesis; Carotid CT Angiogram
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Carotid Artery Diseases; Carotid Stenosis; Constriction, Pathologic
• Other Study ID Numbers: K5-C200

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No