[F-18] RGD-K5 Positron Emission Tomography (PET) in Participants With Carotid Artery Stenosis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01602471 |
Recruitment Status :
Terminated
(Sponsor decided to develop the product in collaboration)
First Posted : May 21, 2012
Results First Posted : September 27, 2013
Last Update Posted : September 27, 2013
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | September 14, 2011 | ||||||
First Posted Date ICMJE | May 21, 2012 | ||||||
Results First Submitted Date ICMJE | July 26, 2013 | ||||||
Results First Posted Date ICMJE | September 27, 2013 | ||||||
Last Update Posted Date | September 27, 2013 | ||||||
Study Start Date ICMJE | May 2012 | ||||||
Actual Primary Completion Date | March 2013 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
[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 ICMJE |
|
||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | [F-18] RGD-K5 Positron Emission Tomography (PET) in Participants With Carotid Artery Stenosis | ||||||
Official Title ICMJE | 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 ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) |
||||||
Condition ICMJE | Carotid Stenosis | ||||||
Intervention ICMJE | 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:
|
||||||
Study Arms ICMJE | Experimental: [F-18]RDG-K5
[F-18]RDG-K5 was administred and PET scan performed
Intervention: Drug: [F-18]RDG-K5
|
||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE |
5 | ||||||
Original Estimated Enrollment ICMJE |
15 | ||||||
Actual Study Completion Date ICMJE | March 2013 | ||||||
Actual Primary Completion Date | March 2013 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender ICMJE |
|
||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01602471 | ||||||
Other Study ID Numbers ICMJE | K5-C200 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Siemens Molecular Imaging | ||||||
Study Sponsor ICMJE | Siemens Molecular Imaging | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
|
||||||
PRS Account | Siemens Molecular Imaging | ||||||
Verification Date | July 2013 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |