Text Size

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

This study is currently recruiting participants.
Verified February 2013 by Siemens Molecular Imaging
Sponsor:
Information provided by (Responsible Party):
Siemens Molecular Imaging
ClinicalTrials.gov Identifier:
NCT01602471
First received: September 14, 2011
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Carotid Stenosis
 Drug: [F-18]RDG-K5
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Further study details as provided by Siemens Molecular Imaging:

Primary Outcome Measures:
  • To assess the uptake of [F-18]RDG-K5 by carotid plaque with Positron Emission Tomography. [ Time Frame: Participants will be followed for an average of 6 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: May 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [F-18]RDG-K5 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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602471

Contacts
Contact: Arkadij Elizarov 310-846 1679 arkadij.elizarov@siemens.com
Contact: Ashok G Chaudhary 215-699 4220 ashok.chaudhary@siemens.com

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Claire Parker     216-445-6821     parkerc@ccf.org    
Contact: Suzanne Fleming     216-444-2521     flemins2@ccf.org    
Principal Investigator: Balaji Tamarappoo, MD, PhD            
Sponsors and Collaborators
Siemens Molecular Imaging
Investigators
Principal Investigator: Balaji Tamarappoo, MD, PhD The Cleveland Clinic
Study Director: Edward Aten, MD President, Certus International
  More Information

No publications provided

Responsible Party: Siemens Molecular Imaging
ClinicalTrials.gov Identifier: NCT01602471     History of Changes
Other Study ID Numbers: K5-C200
Study First Received: September 14, 2011
Last Updated: February 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Siemens Molecular Imaging:
Endarterectomy
K5-C200
RGD-K5
angiogenesis
Carotid CT Angiogram

Additional relevant MeSH terms:
Carotid Stenosis
Constriction, Pathologic
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 21, 2013