Trial Outcomes & Findings for Prospective Analysis of Value of Contrast-enhanced Sonography During Biopsies of Focal Liver Masses (NCT NCT03040323)
NCT ID: NCT03040323
Last Updated: 2019-08-08
Results Overview
Complication will be defined as 1) bleeding seen on post-biopsy CT or US, 2) drop in hemoglobin of more than 1.5 g/dL within one week after biopsy, or 3) need for hepatic artery embolization.
TERMINATED
PHASE4
83 participants
30 days
2019-08-08
Participant Flow
Insufficient patient recruitment and following internal IRB audit study was abandoned/terminated. The PI has left the institution and no information is available regarding how many participants Started and Completed the study in each arm
Participant milestones
| Measure |
Biopsy With Lumason
Lumason 60.7Mg Powder for Injection injected prior to ultrasound-guided biopsy
|
Biopsy With Placebos
Placebos injected prior to ultrasound-guided biopsy.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective Analysis of Value of Contrast-enhanced Sonography During Biopsies of Focal Liver Masses
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 30 daysPopulation: Insufficient patient recruitment and following internal IRB audit study was abandoned/terminated. No data were collected for Outcome Measures
Complication will be defined as 1) bleeding seen on post-biopsy CT or US, 2) drop in hemoglobin of more than 1.5 g/dL within one week after biopsy, or 3) need for hepatic artery embolization.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysPopulation: Insufficient patient recruitment and following internal IRB audit study was abandoned/terminated. No data were collected for Outcome Measures
Biopsy sample being sufficient for histological diagnosis and/or complete genotyping.
Outcome measures
Outcome data not reported
Adverse Events
Biopsy With Lumason
Biopsy With Placebos
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jordan Swensson ,MD
Indiana University Department of Radiology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place