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Trial Outcomes & Findings for [F-18] RGD-K5 Positron Emission Tomography (PET) in Participants With Carotid Artery Stenosis (NCT NCT01602471)

NCT ID: NCT01602471

Last Updated: 2013-09-27

Results Overview

Based on the small sample size and lack of IHC analyses, no efficacy conclusions can be drawn from this study.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Participants will be followed for an average of 6 weeks

Results posted on

2013-09-27

Participant Flow

Five participants enrolled, four complete and one withdrawal prior to receiving the investigational product. Study was terminated early by the sponsor.

Participant milestones

Participant milestones
Measure
[F-18]RDG-K5
\[F-18\]RDG-K5 was administred and PET scan performed
Overall Study
STARTED
4
Overall Study
COMPLETED
4
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
[F-18]RDG-K5
n=4 Participants
\[F-18\]RDG-K5 was administred and PET scan performed
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=5 Participants
Age, Categorical
>=65 years
2 Participants
n=5 Participants
Age Continuous
70.8 years
STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
Region of Enrollment
United States
4 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

[F-18]RDG-K5

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Edward M. Aten, M.D.

Certus International, Inc.

Phone: 603.627.1212

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place