Carotid Stenosis
Conditions
Keywords
Endarterectomy, K5-C200, RGD-K5, angiogenesis, Carotid CT Angiogram
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).
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
Siemens Molecular Imaging
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| [F-18]RDG-K5 Uptake by Carotid Plaque on PET Scan | 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. |
Countries
United States
Participant flow
Recruitment details
Five participants enrolled, four complete and one withdrawal prior to receiving the investigational product. Study was terminated early by the sponsor.
Participants by arm
| Arm | Count |
|---|---|
| [F-18]RDG-K5 \[F-18\]RDG-K5 was administred and PET scan performed | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | [F-18]RDG-K5 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age Continuous | 70.8 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
[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