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

Carotid Stenosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01602471
• Other study ID #: K5-C200
• Status: Terminated
• Phase: Phase 2
• First received: September 14, 2011
• Last updated: July 26, 2013
• Start date: May 2012
• Est. completion date: March 2013

Study information

• Verified date: July 2013
• Source: Siemens Molecular Imaging
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Carotid Stenosis
• Constriction, Pathologic

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Siemens Molecular Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[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	No