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

• Status: Terminated
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Siemens Molecular Imaging

Criteria

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