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

• Sponsor: Siemens Molecular Imaging (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01602471
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Duration (Months): 10
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Stenosis	Drug: [F-18]RDG-K5	Phase 2

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

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• 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 1, 2012
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [F-18]RDG-K5 [F-18]RDG-K5 was administred and PET scan performed	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; Other Names: RGD-K5 K5 [F-18]RGD-K5 PET scan RGD-K5 PET scan K5 PET scan

Outcome Measures

Primary Outcome Measures

1. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• Siemens Molecular Imaging

Investigators

• Principal Investigator: Balaji Tamarappoo, MD, PhD, The Cleveland Clinic
• Study Director: Edward Aten, MD, President, Certus International

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Siemens Molecular Imaging
• ClinicalTrials.gov Identifier: NCT01602471
• Other Study ID Numbers: K5-C200
• First Posted: May 21, 2012
• Last Update Posted: Sep 27, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by Siemens Molecular Imaging: Endarterectomy; K5-C200; RGD-K5; angiogenesis; Carotid CT Angiogram
• Additional relevant MeSH terms: Carotid Stenosis; Constriction, Pathologic

Study Results

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.

Arm/Group Title	[F-18]RDG-K5
Arm/Group Description	[F-18]RDG-K5 was administred and PET scan performed
Period Title: Overall Study
STARTED	4
COMPLETED	4
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	[F-18]RDG-K5
Arm/Group Description	[F-18]RDG-K5 was administred and PET scan performed
Overall Participants	4
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 50%
>=65 years	2 50%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.8 (10.1)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	4 100%
Region of Enrollment (participants) [Number]
United States	4 100%

Outcome Measures

1. Primary Outcome

Title	[F-18]RDG-K5 Uptake by Carotid Plaque on PET Scan
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	[F-18]RDG-K5
Arm/Group Description	[F-18]RDG-K5 was administred and PET scan performed
Measure Participants	0

Adverse Events

Arm/Group Title	[F-18]RDG-K5
Arm/Group Description	[F-18]RDG-K5 was administred and PET scan performed
All Cause Mortality
	[F-18]RDG-K5
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	[F-18]RDG-K5
	Affected / at Risk (%)	# Events
Total	0/4 (0%)
Other (Not Including Serious) Adverse Events
	[F-18]RDG-K5
	Affected / at Risk (%)	# Events
Total	0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.