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

• ClinicalTrials.gov Identifier: NCT01602471
• Recruitment Status: Terminated
• First Posted: May 21, 2012
• Results First Posted: September 27, 2013
• Last Update Posted: September 27, 2013
• Sponsor: Siemens Molecular Imaging
• Information provided by (Responsible Party): Siemens Molecular Imaging

Tracking Information

• First Submitted Date: September 14, 2011
• First Posted Date: May 21, 2012
• Results First Submitted Date: July 26, 2013
• Results First Posted Date: September 27, 2013
• Last Update Posted Date: September 27, 2013
• Study Start Date: May 2012
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 26, 2013)

[F-18]RDG-K5 Uptake by Carotid Plaque on PET Scan [ Time Frame: Participants will be followed for an average of 6 weeks ]

Based on the small sample size and lack of IHC analyses, no efficacy conclusions can be drawn from this study.

Original Primary Outcome Measures (submitted: May 17, 2012)

• To assess if RGD-K5 uptake is visualized in carotid plaque by Positron Emission Tomography. [ Time Frame: Participants will be followed for an average of 6 weeks ]
• 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 ]

• Change History: Complete list of historical versions of study NCT01602471 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: [F-18] RGD-K5 Positron Emission Tomography (PET) in Participants With Carotid Artery Stenosis
• 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
• Brief 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).

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label)
• Condition: Carotid Stenosis

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

Other Names:

• RGD-K5
• K5
• [F-18]RGD-K5 PET scan
• RGD-K5 PET scan
• K5 PET scan

Study Arms

Experimental: [F-18]RDG-K5

[F-18]RDG-K5 was administred and PET scan performed

Intervention: Drug: [F-18]RDG-K5

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 26, 2013): 5
• Original Estimated Enrollment (submitted: May 17, 2012): 15
• Actual Study Completion Date: March 2013
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01602471
• Other Study ID Numbers: K5-C200
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Siemens Molecular Imaging
• Study Sponsor: Siemens Molecular Imaging
• Collaborators: Not Provided

Investigators

• Principal Investigator: Balaji Tamarappoo, MD, PhD; The Cleveland Clinic
• Study Director: Edward Aten, MD; President, Certus International

• PRS Account: Siemens Molecular Imaging
• Verification Date: July 2013