Liver BiopsyPhase 4NCT03040323
Prospective Analysis of Value of Contrast-enhanced Sonography During Biopsies of Focal Liver Masses
A Phase 4 study testing Lumason 60.7Mg Powder for Injection in people with Liver Biopsy, run by Indiana University at 1 site in United States.
Trial summary
The investigators plan to compare complication and success rates between two methods of ultrasound guidance for biopsy of liver lesions, contrast-enhanced and the current protocol without contrast. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Biopsy
- What is being tested?
- Lumason 60.7Mg Powder for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2016to 6 Jul 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females
- Age 18 years or greater
- Scheduled to undergo liver biopsy with ultrasound guidance at a performance site
Who cannot join
- Liver biopsy is not intended to obtain tissue from a specific lesion
- Known or suspected cardiac shunt
- History of hypersensitivity to any active or inactive ingredients in Lumason
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health
Indianapolis, Indiana, 46202
About this study
The investigators plan to compare complication and success rates between two methods of ultrasound guidance for biopsy of liver lesions, contrast-enhanced and the current protocol without contrast.
Read the detailed description
As a major oncology and hepatology center, the investigators perform about 3-5 guided biopsies for liver tumors weekly. Ultrasound is the preferred modality for imaging biopsies due to its ability to visualize and position the biopsy needle in real time with high accuracy and safety, is nonionizing, and is quicker compared to other techniques, especially CT-guided biopsies. The failure rate of ultrasound guided liver biopsies (including cases where biopsy was declined to be performed due to lack of lesion visibility) is about 10%. By comparison, in the investigators' practice genotyping of metastatic tumors, with multiple core biopsies, is often requested for entry into oncology trials, and failure of tumor genotyping after biopsy is estimated to be about 30%.
Recently, the first ultrasound contrast agent was FDA-approved for characterization of liver lesions [sulfur hexafluoride lipid-type A microspheres (Lumason, Bracco Diagnostics, Monroe Township, NJ)]. The microbubble agent is deemed safe, including in cardiac failure patients and those with chronic airway obstruction. Injecting microbubbles may allow better visualization of lesions and adjacent vasculature by enhancing the microvasculature and adjacent vessels and potentially reduce incidence of failed biopsy or bleeding complications. In addition, determination of necrotic regions in a lesion may allow better direction of biopsy.
Yet there is limited literature on the use of ultrasound contrast agents for improving targeted liver biopsies. The investigators intend to prospectively assess the non-diagnostic biopsy and complication rates in a group of patients who undergo contrast-enhanced ultrasonography (CEUS) using microbubbles at the time of biopsy. The investigators will then compare the results from this group with the failure and complication rate from a control group of patients undergoing the standard US-guided biopsy procedure. Over 12 months the investigators expect to perform approximately 200 biopsies. Power analysis suggests that 125 patients in both contrast-enhanced sonography and control groups, each, are required. The investigators should be able to enroll sufficient patients in 18 months
- Conditions
- Liver Biopsy
- Being tested
- Lumason 60.7Mg Powder for Injection, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumason 60.7Mg Powder for InjectionDrug
Also called Lumason
Lumason 60.7Mg Powder for Injection injected prior to ultrasound-guided biopsy
PlacebosDrug
Placebos injected prior to ultrasound-guided biopsy
| Study group | Role | What they receive |
|---|---|---|
| biopsy with Lumason | Experimental | liver biopsy performed with prior contrast enhancement with Lumason 60.7Mg Powder for Injection (experimental method) Receives: Drug: Lumason 60.7Mg Powder for Injection |
| biopsy with placebos | Placebo comparator | liver biopsy performed without prior contrast enhancement (standard method) Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication Rate
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.
Measured: 30 days
Secondary outcomes (1)
Success Rate
Biopsy sample being sufficient for histological diagnosis and/or complete genotyping.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start22 Dec 2016
- Primary completion30 Jun 2018
- Study completion6 Jul 2018
Why it stopped: Insufficient patient recruitment. Data lost following departure of key personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver BiopsyStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two interventional arms, selected by day of month; 1) biopsy with Lumason, 2) biopsy with placebos
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordan K. Swensson, Indiana University
- Investigators
- Kumar Sandrasegaran, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040323
- Sponsor's protocol ID
- 1609504711
- Status last verified
- Jul 2019
- First submitted
- 31 Jan 2017
- Last updated
- 8 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Value of Contrast-enhanced Sonography During Biopsies of Focal Liver Masses
- ClinicalTrials.gov ID
- NCT03040323
- Acronym / sponsor ID
- 1609504711
- Conditions
- Liver Biopsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient patient recruitment. Data lost following departure of key personnel
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 22 Dec 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Posted 24 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators plan to compare complication and success rates between two methods of ultrasound guidance for biopsy of liver lesions, contrast-enhanced and the current protocol without contrast.
Detailed description
As a major oncology and hepatology center, the investigators perform about 3-5 guided biopsies for liver tumors weekly. Ultrasound is the preferred modality for imaging biopsies due to its ability to visualize and position the biopsy needle in real time with high accuracy and safety, is nonionizing, and is quicker compared to other techniques, especially CT-guided biopsies. The failure rate of ultrasound guided liver biopsies (including cases where biopsy was declined to be performed due to lack of lesion visibility) is about 10%. By comparison, in the investigators' practice genotyping of metastatic tumors, with multiple core biopsies, is often requested for entry into oncology trials, and failure of tumor genotyping after biopsy is estimated to be about 30%.
Recently, the first ultrasound contrast agent was FDA-approved for characterization of liver lesions [sulfur hexafluoride lipid-type A microspheres (Lumason, Bracco Diagnostics, Monroe Township, NJ)]. The microbubble agent is deemed safe, including in cardiac failure patients and those with chronic airway obstruction. Injecting microbubbles may allow better visualization of lesions and adjacent vasculature by enhancing the microvasculature and adjacent vessels and potentially reduce incidence of failed biopsy or bleeding complications. In addition, determination of necrotic regions in a lesion may allow better direction of biopsy.
Yet there is limited literature on the use of ultrasound contrast agents for improving targeted liver biopsies. The investigators intend to prospectively assess the non-diagnostic biopsy and complication rates in a group of patients who undergo contrast-enhanced ultrasonography (CEUS) using microbubbles at the time of biopsy. The investigators will then compare the results from this group with the failure and complication rate from a control group of patients undergoing the standard US-guided biopsy procedure. Over 12 months the investigators expect to perform approximately 200 biopsies. Power analysis suggests that 125 patients in both contrast-enhanced sonography and control groups, each, are required. The investigators should be able to enroll sufficient patients in 18 months
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two interventional arms, selected by day of month; 1) biopsy with Lumason, 2) biopsy with placebos
| Arm | Type | Receives |
|---|---|---|
| biopsy with Lumason | Experimental | Drug: Lumason 60.7Mg Powder for Injectionliver biopsy performed with prior contrast enhancement with Lumason 60.7Mg Powder for Injection (experimental method) |
| biopsy with placebos | Placebo comparator | Drug: Placebosliver biopsy performed without prior contrast enhancement (standard method) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females
- Age 18 years or greater
- Scheduled to undergo liver biopsy with ultrasound guidance at a performance site
Key exclusion criteria (3 listed)
- Liver biopsy is not intended to obtain tissue from a specific lesion
- Known or suspected cardiac shunt
- History of hypersensitivity to any active or inactive ingredients in Lumason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumason 60.7Mg Powder for InjectionAlso: LumasonLumason 60.7Mg Powder for Injection injected prior to ultrasound-guided biopsy | Drug | biopsy with Lumason |
| PlacebosPlacebos injected prior to ultrasound-guided biopsy | Drug | biopsy with placebos |
Primary outcome
Complication Rate
Time frame: 30 days
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.
1 secondary outcome
Success Rate
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kumar Sandrasegaran, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lumason 60.7Mg Powder for Injection in people with Liver Biopsy, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication Rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.