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

• ClinicalTrials.gov Identifier: NCT01602471
• Recruitment Status: Terminated
• First Posted: May 21, 2012
• Results First Posted: September 27, 2013
• Last Update Posted: September 27, 2013
• Sponsor: Siemens Molecular Imaging
• Information provided by (Responsible Party): Siemens Molecular Imaging

• Study Type: Interventional
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label)
• Condition: Carotid Stenosis
• Intervention: Drug: [F-18]RDG-K5
• Enrollment: 5

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.
Pre-assignment Details

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 Number of Baseline Participants		4
Baseline Analysis Population Description		Five participants enrolled, four complete and one withdrawal prior to receiving the investigational prodcut. Study was terminated early by the sponsor.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	4 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	2 50.0%
	>=65 years	2 50.0%
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	4 participants
		70.8 (10.1)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	4 participants
	Female	0 0.0%
	Male	4 100.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	4 participants
		4

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
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
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 (%)
Total	--/--
Serious Adverse Events
	[F-18]RDG-K5
	Affected / at Risk (%)
Total	0/4 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	[F-18]RDG-K5
	Affected / at Risk (%)
Total	0/4 (0.00%)

Limitations and 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.

Results Point of Contact

• Name/Title: Edward M. Aten, M.D.
• Organization: Certus International, Inc.
• Phone: 603.627.1212
• EMail: eaten@certusintl.com

• Responsible Party: Siemens Molecular Imaging
• ClinicalTrials.gov Identifier: NCT01602471 History of Changes
• Other Study ID Numbers: K5-C200
• First Submitted: September 14, 2011
• First Posted: May 21, 2012
• Results First Submitted: July 26, 2013
• Results First Posted: September 27, 2013
• Last Update Posted: September 27, 2013