Trial Outcomes & Findings for Dose-Finding, Feasibility Study of Optison in Contrast Enhanced U/S for the Detection of Carotid Artery Disease (NCT NCT01394926)

Results Overview

Assessing the presence of disease of the carotid arteries when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group. Using the optimal dose from 3 different dose levels - 0.15 mL, 0.5 mL and 1.5 mL of Optison.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Up to 10 minutes post contrast administration.

Results posted on

2014-05-02

Participant Flow

21 Subjects enrolled in study. 21 subjects completed this study. 0 subjects did not complete the study.

Participant milestones

Participant milestones
Measure	Optison Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose-Finding, Feasibility Study of Optison in Contrast Enhanced U/S for the Detection of Carotid Artery Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Optison n=21 Participants Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
Age, Continuous	67.3 years STANDARD_DEVIATION 9.40 • n=99 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=99 Participants
Age, Categorical >=65 years	13 Participants n=99 Participants
Sex: Female, Male Female	11 Participants n=99 Participants
Sex: Female, Male Male	10 Participants n=99 Participants
Region of Enrollment United States	21 participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 10 minutes post contrast administration.

Population: Due to difficulty enrolling subjects in all three dose levels of Optison, this study was stopped prematurely. No efficacy analyses were performed.

Assessing the presence of disease of the carotid arteries when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group. Using the optimal dose from 3 different dose levels - 0.15 mL, 0.5 mL and 1.5 mL of Optison.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 10 minutes post contrast administration.

Population: Due to difficulty enrolling subjects in all three dose levels of Optison , this study was stopped prematurely. No efficacy analyses were performed.

Detecting the presence of greater than or equal to 50% stenosis and greater than or equal to 75% stenosis in the carotid arteries when comparing pre contrast to post-contrast U/S by dose group.Using the 3 different dose levels of 0.15 mL, 0.5 mL and 1.5 mL of Optison.

Outcome measures

Outcome data not reported

Adverse Events

Optison

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Optison n=21 participants at risk Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
Nervous system disorders Dysgeusia	9.5% 2/21 • Number of events 2

Additional Information

Paul Sherwin, M.D.

GE Healthcare

Phone: 1-609-514-6820

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place