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

NCT01602471 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2013-09-27

Study results available
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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.

Conditions

  • Carotid Stenosis

Interventions

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

Sponsors & Collaborators

  • Siemens Molecular Imaging

    lead INDUSTRY

Principal Investigators

  • Balaji Tamarappoo, MD, PhD · The Cleveland Clinic

  • Edward Aten, MD · President, Certus International

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01602471 on ClinicalTrials.gov