Trial Outcomes & Findings for Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation (NCT NCT00584402)

Results Overview

After the systemic iv injection of ultrasound contrast, the real time ultrasound images are visually evaluated, and small intrahepatic tumors are detected on the images. The images pre-contrast and post contrast are compared visually. One tumor per participant was analyzed.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

15 min

Results posted on

2017-07-11

Participant Flow

Closed to enrollment

Participant milestones

Participant milestones
Measure	Contrast Sonography Contrast-enhanced sonography perflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Contrast Sonography n=8 Participants Contrast-enhanced sonography perflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex/Gender, Customized Male	5 Participants n=5 Participants
Sex/Gender, Customized Female	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 min

Population: Tumors were evaluated prior and post contrast injection, 1 tumor per participant

After the systemic iv injection of ultrasound contrast, the real time ultrasound images are visually evaluated, and small intrahepatic tumors are detected on the images. The images pre-contrast and post contrast are compared visually. One tumor per participant was analyzed.

Outcome measures

Outcome measures
Measure	Contrast Sonography n=8 tumor Subjects undergoing contrast sonography
Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography	8 tumor

SECONDARY outcome

Timeframe: 15 min

Population: Tumor types showed differences in enhancement

Visual estimation of the the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography using prior assessment or pathology for tumor type

Outcome measures

Outcome measures
Measure	Contrast Sonography n=8 Participants Subjects undergoing contrast sonography
Number of Participants With an Increase in Echogenicity (Brightness) of Small Intrahepatic Tumors Following Contrast-enhanced Sonography Based on Tumor Type, Size, Location and Depth	8 participants

Adverse Events

Contrast Sonography

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

John McGahan, M.D.

University of Califonia, Davis

Phone: (916)734-0519

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60