Adult Primary Liver CancerNCT01908166
Ultrasound Elastography in Diagnosing Patients With Kidney or Liver Solid Focal Lesions
A study testing ultrasound elasticity imaging in people with Adult Primary Liver Cancer and Kidney Tumor, run by Stanford University at 1 site in United States.
Trial summary
This clinical trial studies ultrasound elastography in diagnosing patients with kidney or liver solid focal lesions. New diagnostic procedures, such as ultrasound elastography, may be a less invasive way to check for kidney or liver solid focal lesions. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Adult Primary Liver Cancer, Kidney Tumor
- What is being tested?
- ultrasound elasticity imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 1 Nov 2016
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- There are no restrictions on life expectancy
- Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will not be employed
- Patients of any ethnic background
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients should not be taking other investigational agents
- No requirements due to co-morbid disease or intercurrent illness, as needed
- No restrictions on allergic reactions as no imaging agent will be used
- Concomitant medications for treatment of the target lesion
- Pregnant or nursing patients will be excluded from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Stanford, California, 94305
About this study
Official title: US Elastography for Characterizing Focal Lesions in the Liver and Kidney
This clinical trial studies ultrasound elastography in diagnosing patients with kidney or liver solid focal lesions. New diagnostic procedures, such as ultrasound elastography, may be a less invasive way to check for kidney or liver solid focal lesions.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the utility of ultrasound elastography in correlation with kidney or liver biopsy or magnetic resonance imaging (MRI) or computed tomography (CT) results.
OUTLINE:
Patients undergo ultrasound elastography.
- Conditions
- Adult Primary Liver Cancer, Kidney Tumor
- Being tested
- ultrasound elasticity imaging
- Medical subject headings
- Carcinoma, Hepatocellular, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound elasticity imagingProcedure or surgery
Undergo ultrasound elastography
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (ultrasound elastography) | Experimental | Patients undergo ultrasound elastography. Receives: Procedure: ultrasound elasticity imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strain ratio for all lesions measured by comparing the lesion to the adjacent normal tissue
Suspicious liver and kidney lesions will be analyzed separately on a per-lesion basis. Within each population, the strain ratio of cases and controls will be compared using the Wilcoxon rank sum test, and the analysis will be illustrated using the non-parametric receiver operating characteristic (ROC).
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJan 2014
- Primary completion1 Nov 2016
- Study completion1 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Primary Liver CancerStudies of the same condition, open and under way.
- More trials run by Stanford 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Juergen Willmann, Stanford University
- Investigators
- Juergen Willmann, Principal investigator, Stanford University Hospitals and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908166
- Sponsor's protocol ID
- VAR0099
- Other IDs
- NCI-2013-01353, P30CA124435
- Status last verified
- Jun 2017
- First submitted
- 23 Jul 2013
- Last updated
- 8 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- US Elastography for Characterizing Focal Lesions in the Liver and Kidney
- ClinicalTrials.gov ID
- NCT01908166
- Acronym / sponsor ID
- VAR0099
- Conditions
- Adult Primary Liver Cancer, Kidney Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2014
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 1 Nov 2016 (actual)
- First posted
- 25 Jul 2013 (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.
This clinical trial studies ultrasound elastography in diagnosing patients with kidney or liver solid focal lesions. New diagnostic procedures, such as ultrasound elastography, may be a less invasive way to check for kidney or liver solid focal lesions.
Detailed description
PRIMARY OBJECTIVES:
- To determine the utility of ultrasound elastography in correlation with kidney or liver biopsy or magnetic resonance imaging (MRI) or computed tomography (CT) results.
OUTLINE:
Patients undergo ultrasound elastography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (ultrasound elastography) | Experimental | Procedure: ultrasound elasticity imagingPatients undergo ultrasound elastography. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- There are no restrictions on life expectancy
- Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will not be employed
- Patients of any ethnic background
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (5 listed)
- Patients should not be taking other investigational agents
- No requirements due to co-morbid disease or intercurrent illness, as needed
- No restrictions on allergic reactions as no imaging agent will be used
- Concomitant medications for treatment of the target lesion
- Pregnant or nursing patients will be excluded from the study
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 |
|---|---|---|
| ultrasound elasticity imagingUndergo ultrasound elastography | Procedure or surgery | Diagnostic (ultrasound elastography) |
Primary outcome
Strain ratio for all lesions measured by comparing the lesion to the adjacent normal tissue
Time frame: Up to 36 months
Suspicious liver and kidney lesions will be analyzed separately on a per-lesion basis. Within each population, the strain ratio of cases and controls will be compared using the Wilcoxon rank sum test, and the analysis will be illustrated using the non-parametric receiver operating characteristic (ROC).
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 8 Jun 2017.
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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.
Juergen Willmann principal investigator
Stanford University Hospitals and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound elasticity imaging in people with Adult Primary Liver Cancer and Kidney Tumor, run by Stanford 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 4 inclusion and 5 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 8 Jun 2017. 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.
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?
Strain ratio for all lesions measured by comparing the lesion to the adjacent normal tissue (time frame: Up to 36 months). 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 Jun 2017.