Liver TumorsPhase 1Definity®NCT00955097
Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors
A Phase 1 study testing Definity® in people with Liver Tumors, run by University of Louisville at 2 sites in United States.
Trial summary
The primary purpose of this study is to demonstrate the safety and effectiveness of using an intra-operative ultrasound contrast agent(Definity®) for the identification of known liver tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Tumors
- What is being tested?
- Definity®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to May 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Undergoing a hepatic resection or hepatic ablation of pre-operative visualized liver tumor:
- ≥ 18 years of age
- If female of child-bearing potential, negative pregnancy test within 14 days prior to surgery
- If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits.
- IRB-approved informed consent, signed by the subject or the subject's legally authorized representative. ≥ 18 years of age
Who cannot join
- 1. Not a suitable candidate for operation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Norton Healthcare
Louisville, Kentucky, 40202
University of Louisville Hospital
Louisville, Kentucky, 40202
About this study
The primary purpose of this study is to demonstrate the safety and effectiveness of using an intra-operative ultrasound contrast agent(Definity®) for the identification of known liver tumors.
Read the detailed description
The primary objective of this study is to demonstrate the safety of the use of intra-operative ultrasound contrast (Definity®) administration. The secondary objective of this study is to demonstrate the improved image quality and conspicuity of known liver tumors using contrast enhancement.
- Conditions
- Liver Tumors
- Being tested
- Definity®
- Keywords
- Definity, liver tumors, intra operative contrast, liver cancer, hepatic tumors, identify liver tumors, surgery liver tumors, Patients with known hepatic tumors
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Definity®Drug
Definity® injections given both pre-ablation and post-ablation
| Study group | Role | What they receive |
|---|---|---|
| Definity Contrast Dye | Experimental | During liver surgery Definity contrast dye will be administered follwed by an ultrasound to better detect liver tumors Receives: Drug: Definity® |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
Measured: 6-weeks post surgery
identification of liver tumors
Measured: intra-operative
Secondary outcomes (1)
improved ablation of liver tumors
Measured: 6-weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startMay 2008
- Primary completionJun 2009
- Study completionMay 2010
Why it stopped: No funding for this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TumorsStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert C. Martin, University of Louisville
- Investigators
- Robert Martin, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955097
- Sponsor's protocol ID
- Definity 08.0119
- Other IDs
- 08.0119
- Acronym
- Definity®
- Status last verified
- Oct 2013
- First submitted
- 6 Aug 2009
- Last updated
- 21 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors
- ClinicalTrials.gov ID
- NCT00955097
- Acronym / sponsor ID
- Definity® / Definity 08.0119
- Conditions
- Liver Tumors
- Keywords
- Definity, liver tumors, intra operative contrast, liver cancer, hepatic tumors, identify liver tumors, surgery liver tumors, Patients with known hepatic tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No funding for this study
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 7 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to demonstrate the safety and effectiveness of using an intra-operative ultrasound contrast agent(Definity®) for the identification of known liver tumors.
Detailed description
The primary objective of this study is to demonstrate the safety of the use of intra-operative ultrasound contrast (Definity®) administration. The secondary objective of this study is to demonstrate the improved image quality and conspicuity of known liver tumors using contrast enhancement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Definity Contrast Dye | Experimental | Drug: Definity®During liver surgery Definity contrast dye will be administered follwed by an ultrasound to better detect liver tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Undergoing a hepatic resection or hepatic ablation of pre-operative visualized liver tumor:
- ≥ 18 years of age
- If female of child-bearing potential, negative pregnancy test within 14 days prior to surgery
- If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits.
- IRB-approved informed consent, signed by the subject or the subject's legally authorized representative. ≥ 18 years of age
Key exclusion criteria (1 listed)
- 1. Not a suitable candidate for operation
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 |
|---|---|---|
| Definity®Definity® injections given both pre-ablation and post-ablation | Drug | Definity Contrast Dye |
Primary outcome
adverse events
Time frame: 6-weeks post surgery
identification of liver tumors
Time frame: intra-operative
1 secondary outcome
improved ablation of liver tumors
Time frame: 6-weeks post surgery
Results and safety
The study was stopped early (reason given: No funding for this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2013.
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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.
Robert Martin, MD principal investigator
University of Louisville
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Definity® in people with Liver Tumors, run by University of Louisville at 2 sites 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 5 inclusion and 1 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 21 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No funding for this study). Results are not available in the source record.
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?
adverse events (time frame: 6-weeks post surgery). The study lists 2 primary outcomes in all. 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 21 Oct 2013.