CirrhosisEarly Phase 1NCT03407001
Contrast Enhanced Ultrasound With Lumason in Detecting Liver Cancer in Participants With Cirrhosis
A Early Phase 1 study testing Contrast-Enhanced Ultrasound, Sulfur Hexafluoride Lipid Microspheres and Ultrasound in people with Cirrhosis, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This early phase I trial studies how well contrast enhanced ultrasound with sulfur hexafluoride lipid microspheres (Lumason) works in detecting liver cancer in participants with cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Contrast-Enhanced Ultrasound, Sulfur Hexafluoride Lipid Microspheres and Ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2018to 15 Sep 2020
- Phase
- Early 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
- Able and willing to provide written informed consent
- Diagnosis of cirrhosis based on one or more of the following: histology, US, computed tomography (CT) or MRI showing cirrhosis, +/- lesions seen on CE-MRI
Who cannot join
- History of hypersensitivity to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason
- Pregnant patients-excluded by history
- Pediatric patients, as pediatric cirrhosis is uncommon
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lesion Detection in Cirrhotic Patients With Contrast Enhanced Ultrasound and the Accuracy of Contrast Enhanced Ultrasound Li-RADS for Hepatocellular Carcinoma Diagnosis
This early phase I trial studies how well contrast enhanced ultrasound with sulfur hexafluoride lipid microspheres (Lumason) works in detecting liver cancer in participants with cirrhosis. Contrast enhanced-ultrasounds use contrast agents, such as Lumason, that are injected into a vein in order to help certain organs and tissues show up more clearly on scans. Contrast enhanced ultrasound with Lumason may help doctors more easily find liver cancer compared to ultrasounds without contrast agent.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the accuracy of contrast enhanced ultrasound (CEUS) utilizing contrast agent sulfur hexafluoride lipid-type A microspheres compared to B-mode non-contrast enhanced ultrasound for liver lesion detection, including hepatocellular carcinoma (HCC), in cirrhotic ultrasound (US) patients.
SECONDARY OBJECTIVES:
- Determine the concordance of CEUS vs. contrast enhanced magnetic resonance imaging (CE-MRI) Liver Imaging Reporting and Data Systems (Li-Rads).
OUTLINE:
Within 30 days of routine MRI, participants undergo non-contrast ultrasound of the abdomen. Participants then receive Lumason intravenously (IV) and undergo contrast-enhanced ultrasound of the abdomen over 1 hour.
- Conditions
- Cirrhosis
- Being tested
- Contrast-Enhanced Ultrasound, Sulfur Hexafluoride Lipid Microspheres, Ultrasound
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-Enhanced UltrasoundProcedure or surgery
Also called CEUS
Undergo CEUS
Sulfur Hexafluoride Lipid MicrospheresDrug
Also called Lumason, SF6 Lipid Microspheres, Sulfur Hexafluoride Lipid-type A Microspheres
Given IV
UltrasoundProcedure or surgery
Undergo non-contrast US
| Study group | Role | What they receive |
|---|---|---|
| Screening (US, CEUS, Lumason) | Experimental | Within 30 days of routine MRI, participants undergo non-contrast ultrasound of the abdomen. Participants then receive Lumason IV and undergo contrast-enhanced ultrasound of the abdomen over 1 hour in the absence of disease progression or unacceptable toxicity. Receives: Procedure: Contrast-Enhanced Ultrasound; Drug: Sulfur Hexafluoride Lipid Microspheres; Procedure: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of contrast enhanced ultrasound (CEUS) with contrast agent sulfur hexafluoride lipid-type A microspheres and B-mode non-contrast enhanced ultrasound
The study will estimate the sensitivity of ultrasound (US) and CEUS in patients with detectable lesions on magnetic resonance imaging (MRI). The analysis will be conducted at the patient level with a binary outcome of 0 if the patient has no detectable lesions and 1 if the patient has one or more detectable lesions. The study will use McNemar's test to compare US vs. CEUS in patients with any detectable lesions on MRI. The test assesses whether the two tests have equivalent marginal probabilities (i.e. probability of detecting at least one lesion with US and CEUS is equivalent). McNemar's test statistic depends only on patients where US and CEUS disagree.
Measured: Up to 3 years
Secondary outcomes (1)
Assessment of CEUS and contrast enhanced magnetic resonance imaging (CE-MRI) Liver Imaging Reporting and Data Systems (Li-Rads)
The study will assess the concordance between CEUS Li-Rads and MRI Li-Rads scoring results for each lesion using a multinomial logit random effects model. The study will summarize the characteristics (the size, location, vascularity and enhancement pattern) of lesions detected by only one imaging modality, stratified by imaging type.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start12 Jan 2018
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ott Le, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407001
- Sponsor's protocol ID
- 2017-0691
- Other IDs
- NCI-2018-00895, 2017-0691, P30CA016672, R01CA195524
- Status last verified
- Oct 2020
- First submitted
- 16 Jan 2018
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lesion Detection in Cirrhotic Patients With Contrast Enhanced Ultrasound and the Accuracy of Contrast Enhanced Ultrasound Li-RADS for Hepatocellular Carcinoma Diagnosis
- ClinicalTrials.gov ID
- NCT03407001
- Acronym / sponsor ID
- 2017-0691
- Conditions
- Cirrhosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 23 Jan 2018 (actual)
- 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.
This early phase I trial studies how well contrast enhanced ultrasound with sulfur hexafluoride lipid microspheres (Lumason) works in detecting liver cancer in participants with cirrhosis. Contrast enhanced-ultrasounds use contrast agents, such as Lumason, that are injected into a vein in order to help certain organs and tissues show up more clearly on scans. Contrast enhanced ultrasound with Lumason may help doctors more easily find liver cancer compared to ultrasounds without contrast agent.
Detailed description
PRIMARY OBJECTIVES:
- Determine the accuracy of contrast enhanced ultrasound (CEUS) utilizing contrast agent sulfur hexafluoride lipid-type A microspheres compared to B-mode non-contrast enhanced ultrasound for liver lesion detection, including hepatocellular carcinoma (HCC), in cirrhotic ultrasound (US) patients.
SECONDARY OBJECTIVES:
- Determine the concordance of CEUS vs. contrast enhanced magnetic resonance imaging (CE-MRI) Liver Imaging Reporting and Data Systems (Li-Rads).
OUTLINE:
Within 30 days of routine MRI, participants undergo non-contrast ultrasound of the abdomen. Participants then receive Lumason intravenously (IV) and undergo contrast-enhanced ultrasound of the abdomen over 1 hour.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (US, CEUS, Lumason) | Experimental | Procedure: Contrast-Enhanced Ultrasound, Drug: Sulfur Hexafluoride Lipid Microspheres, Procedure: UltrasoundWithin 30 days of routine MRI, participants undergo non-contrast ultrasound of the abdomen. Participants then receive Lumason IV and undergo contrast-enhanced ultrasound of the abdomen over 1 hour in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able and willing to provide written informed consent
- Diagnosis of cirrhosis based on one or more of the following: histology, US, computed tomography (CT) or MRI showing cirrhosis, +/- lesions seen on CE-MRI
Key exclusion criteria (3 listed)
- History of hypersensitivity to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason
- Pregnant patients-excluded by history
- Pediatric patients, as pediatric cirrhosis is uncommon
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 |
|---|---|---|
| Contrast-Enhanced UltrasoundAlso: CEUSUndergo CEUS | Procedure or surgery | Screening (US, CEUS, Lumason) |
| Sulfur Hexafluoride Lipid MicrospheresAlso: Lumason, SF6 Lipid Microspheres, Sulfur Hexafluoride Lipid-type A MicrospheresGiven IV | Drug | Screening (US, CEUS, Lumason) |
| UltrasoundUndergo non-contrast US | Procedure or surgery | Screening (US, CEUS, Lumason) |
Primary outcome
Accuracy of contrast enhanced ultrasound (CEUS) with contrast agent sulfur hexafluoride lipid-type A microspheres and B-mode non-contrast enhanced ultrasound
Time frame: Up to 3 years
The study will estimate the sensitivity of ultrasound (US) and CEUS in patients with detectable lesions on magnetic resonance imaging (MRI). The analysis will be conducted at the patient level with a binary outcome of 0 if the patient has no detectable lesions and 1 if the patient has one or more detectable lesions. The study will use McNemar's test to compare US vs. CEUS in patients with any detectable lesions on MRI. The test assesses whether the two tests have equivalent marginal probabilities (i.e. probability of detecting at least one lesion with US and CEUS is equivalent). McNemar's test statistic depends only on patients where US and CEUS disagree.
1 secondary outcome
Assessment of CEUS and contrast enhanced magnetic resonance imaging (CE-MRI) Liver Imaging Reporting and Data Systems (Li-Rads)
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Ott Le principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Contrast-Enhanced Ultrasound, Sulfur Hexafluoride Lipid Microspheres and Ultrasound in people with Cirrhosis, run by M.D. Anderson Cancer Center 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 2 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: finished, as of the sponsor's last update on 14 Oct 2020. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accuracy of contrast enhanced ultrasound (CEUS) with contrast agent sulfur hexafluoride lipid-type A microspheres and B-mode non-contrast enhanced ultrasound (time frame: Up to 3 years). 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 14 Oct 2020.