TRACER RGD-K5 Carotid Plaque Imaging Study
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate the ability of the compound[F-18]RGD-K5, when used as a tracer during PET (positron emission tomography) imaging, to detect regions of unstable atherosclerotic plaque in the carotid artery of subjects being considered for carotid endarterectomy (CEA),and to confirm this ability through histological studies of samples of carotid artery plaques that will be collected during the planned carotid surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Patients will be chosen for the study based on presence of carotid artery stenosis ascertained by CTA and carotid artery ultrasound. Patients will receive and intravenous injection of the radiolabeled PET tracer,[F-18]RGD-K5, and will undergo PET imaging of their carotid arteries bilaterally. PET images will be analyzed to determine the standard uptake value (SUV) of [F-18]RGD-K5 uptake by the carotid artery plaque and this will be compared to the SUV of the background (blood pool in the aorta). This will be expressed as a target to background ratio (TBR). Investigators expect to find a significant uptake of [F-18]RGD-K5 by carotid artery palque and investigators therefore expect to find a TBR that is significantly
- Investigators also expect to find that plaque from patients who show a TBR >1 will also be enriched for histologic markers for inflammation and angiogenesis.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PET imaging with [F-18] RDG-K5 This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging. |
Drug: [F-18] RDG-K5
Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Target to Background Ratio (TBR) [Baseline]
To assess uptake of [F-18]RGD-K5 by carotid plaque with PET/CT imaging (which will be expressed as a target to background ratio (TBR) of the standard uptake value (SUV)) in participants prior to carotid endarterectomy. The TBR of [F-18]RGD-K5 in the plaque will serve as a surrogate marker of plaque inflammation in participants being considered for carotid endarterectomy.
Eligibility Criteria
Criteria
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 >50% luminal diameter based on carotid ultrasound or computed tomography angiography (CTA), as stated in official clinical report or as measured by PI if no quantitative assessment appears in the report, and who is deemed to be a surgical candidate for endarterectomy
-
Participant has had a carotid ultrasound and/or computed tomography angiography (CTA) and the report is available for collection
-
Participant has had or is scheduled to have a carotid CT angiogram for plaque localization within 60 days of signing ICF (or else scheduled 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 functions 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:
-
Female participant is nursing
-
Female 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- The Cleveland Clinic
Investigators
- Principal Investigator: Balaji Tamarappoo, MD, PhD, The Cleveland Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- K5 IND
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | PET Imaging With [F-18] RDG-K5 |
|---|---|
| Arm/Group Description | This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging. [F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5 |
| Period Title: Overall Study | |
| STARTED | 3 |
| COMPLETED | 1 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | PET Imaging With [F-18] RDG-K5 |
|---|---|
| Arm/Group Description | This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging. [F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5 |
| Overall Participants | 3 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
1
33.3%
|
| Male |
2
66.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
3
100%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
3
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
Outcome Measures
| Title | Target to Background Ratio (TBR) |
|---|---|
| Description | To assess uptake of [F-18]RGD-K5 by carotid plaque with PET/CT imaging (which will be expressed as a target to background ratio (TBR) of the standard uptake value (SUV)) in participants prior to carotid endarterectomy. The TBR of [F-18]RGD-K5 in the plaque will serve as a surrogate marker of plaque inflammation in participants being considered for carotid endarterectomy. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| no subject analysis done |
| Arm/Group Title | PET Imaging With [F-18] RDG-K5 |
|---|---|
| Arm/Group Description | This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging. [F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5 |
| Measure Participants | 0 |
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | PET Imaging With [F-18] RDG-K5 | |
| Arm/Group Description | This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging. [F-18] RDG-K5: Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5 | |
All Cause Mortality |
||
| PET Imaging With [F-18] RDG-K5 | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| PET Imaging With [F-18] RDG-K5 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| PET Imaging With [F-18] RDG-K5 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Balaji Tamarappoo |
|---|---|
| Organization | Cleveland Clinic |
| Phone | 216-444-6765 |
| tamarab@ccf.org |
- K5 IND