Trial Outcomes & Findings for Feasibility 3D Perfusion Ultrasound for Liver Cancer SABR Planning and Response Evaluation (NCT NCT02424955)

Last Updated: 2023-07-11

Results Overview

The purpose of this pilot project is to prospectively analyze the value of 3D ultrasound perfusion imaging for treatment planning, the prediction of therapy success, and to monitor the treatment response in patients with a primary or metastatic liver tumor undergoing radiation treatment.

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.

Results posted on

2023-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	3D Perfusion Ultrasound Patients undergo 3D ultrasound perfusion imaging with perflutren lipid microspheres
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility 3D Perfusion Ultrasound for Liver Cancer SABR Planning and Response Evaluation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	3D Perfusion Ultrasound n=11 Participants Patients undergo 3D ultrasound perfusion imaging with perflutren lipid microspheres
Age, Customized 50-59	3 Participants n=5 Participants
Age, Customized 60-69	2 Participants n=5 Participants
Age, Customized 70-79	5 Participants n=5 Participants
Age, Customized 80-89	1 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.

Population: No cases were analyzed; analysis was not possible due to poor image quality.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.

Population: No cases were analyzed; analysis was not possible due to poor image quality.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.

Population: No cases were analyzed; analysis was not possible due to poor image quality.

Outcome measures

Outcome data not reported

Adverse Events

3D Perfusion Ultrasound

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

Lucas Kas Vitzthum

Stanford University

Phone: (650) 498-6000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place