Carotid StenosisPhase 2NCT01602471
[F-18] RGD-K5 Positron Emission Tomography (PET) in Participants With Carotid Artery Stenosis
A Phase 2 study testing [F-18]RDG-K5 in people with Carotid Stenosis, run by Siemens Molecular Imaging at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- [F-18]RDG-K5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Mar 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Carotid Stenosis
- Being tested
- [F-18]RDG-K5
- Keywords
- Endarterectomy, K5-C200, RGD-K5, angiogenesis, Carotid CT Angiogram
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[F-18]RDG-K5Drug
Also called RGD-K5, K5, [F-18]RGD-K5 PET scan, RGD-K5 PET scan
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
| Study group | Role | What they receive |
|---|---|---|
| [F-18]RDG-K5 | Experimental | [F-18]RDG-K5 was administred and PET scan performed Receives: Drug: [F-18]RDG-K5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
[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.
Measured: Participants will be followed for an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Sponsor decided to develop the product in collaboration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Molecular Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Balaji Tamarappoo, MD, PhD, Principal investigator, The Cleveland ClinicEdward Aten, MD, Study director, President, Certus International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602471
- Sponsor's protocol ID
- K5-C200
- Status last verified
- Jul 2013
- First submitted
- 14 Sep 2011
- Last updated
- 27 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01602471
- Acronym / sponsor ID
- K5-C200
- Conditions
- Carotid Stenosis
- Keywords
- Endarterectomy, K5-C200, RGD-K5, angiogenesis, Carotid CT Angiogram
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decided to develop the product in collaboration
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Siemens Molecular ImagingIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 May 2012 (estimated)
- Results
- Posted 27 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [F-18]RDG-K5 | Experimental | Drug: [F-18]RDG-K5[F-18]RDG-K5 was administred and PET scan performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [F-18]RDG-K5Also: RGD-K5, K5, [F-18]RGD-K5 PET scan, RGD-K5 PET scanApproximately fifteen (15) patients with carotid artery stenosis > 69% will undergo an endarterectomy and will be imaged under PET/CT with [F-18]RGD-K5 | Drug | [F-18]RDG-K5 |
Primary outcome
[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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Carotid Stenosis
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruitingObservational study
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
Carotid Artery Stenosis
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Balaji Tamarappoo, MD, PhD principal investigator
The Cleveland Clinic
Edward Aten, MD study director
President, Certus International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [F-18]RDG-K5 in people with Carotid Stenosis, run by Siemens Molecular Imaging at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[F-18]RDG-K5 Uptake by Carotid Plaque on PET Scan (time frame: Participants will be followed for an average of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2013.