A Phase 2 interventional study of [F-18]RDG-K5 in Carotid Stenosis, sponsored by Siemens Molecular Imaging. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-27.
Sponsored by Siemens Molecular Imaging · Phase 2 and Interventional
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.
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).
339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.
This study's enrollment of 5 is below the median of 106 across 182 interventional studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →Siemens Molecular Imaging is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
\[F-18\]RDG-K5 was administred and PET scan performed
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
Also known as: RGD-K5, K5, [F-18]RGD-K5 PET scan, RGD-K5 PET scan, K5 PET scan
[F-18]RDG-K5 Uptake by Carotid Plaque on PET Scan
Based on the small sample size and lack of IHC analyses, no efficacy conclusions can be drawn from this study.
Time frame: Participants will be followed for an average of 6 weeks
Five participants enrolled, four complete and one withdrawal prior to receiving the investigational product. Study was terminated early by the sponsor.
| Milestone | [F-18]RDG-K5 |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
Based on the small sample size and lack of IHC analyses, no efficacy conclusions can be drawn from this study.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| [F-18]RDG-K5 | — | 0/4 (0%) | 0/4 (0%) |
Five participants enrolled, four complete and one withdrawal prior to receiving the investigational prodcut. Study was terminated early by the sponsor.
| Age, Categorical(Participants) | [F-18]RDG-K5 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 2 |
| Age Continuous(years) | [F-18]RDG-K5 |
|---|---|
| Mean | 70.8 ± 10.1 |
| Sex: Female, Male(Participants) | [F-18]RDG-K5 |
|---|---|
| Female | 0 |
| Male | 4 |
| Region of Enrollment(participants) | [F-18]RDG-K5 |
|---|---|
| United States | 4 |
This study is terminated, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Siemens Molecular Imaging