[F-18] RGD-K5 Positron Emission Tomography (PET) in Participants With Carotid Artery Stenosis
|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
|Condition or disease||Intervention/treatment||Phase|
|Carotid Stenosis||Drug: [F-18]RDG-K5||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
[F-18]RDG-K5 was administred and PET scan performed
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
- [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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602471
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Balaji Tamarappoo, MD, PhD||The Cleveland Clinic|
|Study Director:||Edward Aten, MD||President, Certus International|