[F-18] RGD-K5 Positron Emission Tomography (PET) in Participants With Carotid Artery Stenosis

NCT01602471 | Terminated Phase 2 Results

• 1 other identifier: K5-C200
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Stenosis

Keywords

Endarterectomy; K5-C200; RGD-K5; angiogenesis; Carotid CT Angiogram

Outcome Measures

Primary Outcomes (1)

• [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.

  Participants will be followed for an average of 6 weeks

Study Arms (1)

[F-18]RDG-K5

EXPERIMENTAL

\[F-18\]RDG-K5 was administred and PET scan performed

Drug: [F-18]RDG-K5

Interventions

[F-18]RDG-K5 DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siemens Molecular Imaging: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Carotid Stenosis

Interventions

18F-RGD-K5

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Edward M. Aten, M.D.
• Organization: Certus International, Inc.

eaten@certusintl.com

603.627.1212

Study Officials

• Balaji Tamarappoo, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Edward Aten, MD

  President, Certus International

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: May 21, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 27, 2013
• Results First Posted: September 27, 2013

Record last verified: 2013-07

Locations

US (1)