CirrhosisNCT02774161
B-mode Ultrasound Imaging in Detecting Early Liver Cancer
A study testing Ultrasound Tomography in people with Cirrhosis and Early Hepatocellular Carcinoma, run by Stanford University at 1 site in United States.
Trial summary
This pilot trial studies how well B-mode ultrasound imaging works in detecting liver cancer that is early in its growth and may not have spread to other parts of the body. Diagnostic procedures, such as B-mode ultrasound imaging, may help find and diagnose liver cancer and find out how far the disease has spread. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis, Early Hepatocellular Carcinoma, Fibrosis
- What is being tested?
- Ultrasound Tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 19 Jun 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For Healthy Volunteers
- Patients over 18 years of age.
- Must have no known medical problems and have had a full medical exam within 6 months of the study. If healthy volunteers have not had a full medical exam within 6 months of the study, one of the ultrasound physicians will conduct the medical exam prior to any study procedures.
- For HCC patients
- Patients over 18 years of age.
- Patient with confirmed diagnosis of HCC, and untreated or Patients with Suspected HCC (Suspected HCC nodules should preferably be smaller than 3 cm and preferably within 6 cm in depth of the transducer head to minimize attenuation) and untreated or Patients at a higher risk of HCC undergoing a screening program by Ultrasound.
Who cannot join
- For Healthy volunteers
- 1. Patients who are not likely to comply with the protocol requirements.
- For HCC patients
- Patients should not be taking other Investigational Agents.
- Concomitant medications for treatment of the target lesion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Palo Alto, California, 94305
About this study
Official title: Quantitative Ultrasound Spectroscopy to Early HCC
This pilot trial studies how well B-mode ultrasound imaging works in detecting liver cancer that is early in its growth and may not have spread to other parts of the body. Diagnostic procedures, such as B-mode ultrasound imaging, may help find and diagnose liver cancer and find out how far the disease has spread.
Read the detailed description
PRIMARY OBJECTIVES:
- To investigate the use of quantitative ultrasound spectroscopy to detect early hepatocellular carcinoma (HCC) as an inexpensive and widely available quantitative (i.e. robust) method to confirm disease in developing countries.
OUTLINE:
Patients undergo B-mode ultrasound imaging of the liver over 15 minutes.
- Conditions
- Cirrhosis, Early Hepatocellular Carcinoma, Fibrosis, Stage I Hepatocellular Carcinoma, Stage II Hepatocellular Carcinoma
- Being tested
- Ultrasound Tomography
- Medical subject headings
- Fibrosis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound TomographyOther
Undergo B-mode ultrasound imaging
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (B-mode ultrasound imaging) | Experimental | Patients undergo B-mode ultrasound imaging of the liver over 15 minutes. Receives: Other: Ultrasound Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mid-band fit
The Mid-band fit is related to the intensity of the returned ultrasound signal at different frequencies has been shown to change with tissue morphology.
Measured: Up to 16 months
Spectral intercept
Spectral intercept (SI) is mostly related to the number scatterers and their density in the tissue. Changes in the SI have been demonstrated to occur due to different pathologies and result from treatments that change the structure of the tissue being imaged.
Measured: Up to 16 months
Spectral slope
Summarized as the maximum and/or average value over the lesion of interest (using a region of interest selection) and the liver image as a whole.
Measured: Up to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startMay 2016
- Primary completion19 Jun 2017
- Study completion19 Jun 2017
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 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Kamaya, Stanford University
- Investigators
- Aya Kamaya, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774161
- Sponsor's protocol ID
- IRB-36299
- Other IDs
- NCI-2016-00663, GIIMG0007
- Status last verified
- Aug 2021
- First submitted
- 2 May 2016
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Ultrasound Spectroscopy to Early HCC
- ClinicalTrials.gov ID
- NCT02774161
- Acronym / sponsor ID
- IRB-36299
- Conditions
- Cirrhosis, Early Hepatocellular Carcinoma, Fibrosis, Stage I Hepatocellular Carcinoma, Stage II Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- 19 Jun 2017 (actual)
- Study completion
- 19 Jun 2017 (actual)
- First posted
- 17 May 2016 (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 pilot trial studies how well B-mode ultrasound imaging works in detecting liver cancer that is early in its growth and may not have spread to other parts of the body. Diagnostic procedures, such as B-mode ultrasound imaging, may help find and diagnose liver cancer and find out how far the disease has spread.
Detailed description
PRIMARY OBJECTIVES:
- To investigate the use of quantitative ultrasound spectroscopy to detect early hepatocellular carcinoma (HCC) as an inexpensive and widely available quantitative (i.e. robust) method to confirm disease in developing countries.
OUTLINE:
Patients undergo B-mode ultrasound imaging of the liver over 15 minutes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (B-mode ultrasound imaging) | Experimental | Other: Ultrasound TomographyPatients undergo B-mode ultrasound imaging of the liver over 15 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- For Healthy Volunteers
- Patients over 18 years of age.
- Must have no known medical problems and have had a full medical exam within 6 months of the study. If healthy volunteers have not had a full medical exam within 6 months of the study, one of the ultrasound physicians will conduct the medical exam prior to any study procedures.
- For HCC patients
- Patients over 18 years of age.
Key exclusion criteria (5 listed)
- For Healthy volunteers
- 1. Patients who are not likely to comply with the protocol requirements.
- For HCC patients
- Patients should not be taking other Investigational Agents.
- Concomitant medications for treatment of the target lesion.
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 TomographyUndergo B-mode ultrasound imaging | Other | Diagnostic (B-mode ultrasound imaging) |
Primary outcome
Mid-band fit
Time frame: Up to 16 months
The Mid-band fit is related to the intensity of the returned ultrasound signal at different frequencies has been shown to change with tissue morphology.
Spectral intercept
Time frame: Up to 16 months
Spectral intercept (SI) is mostly related to the number scatterers and their density in the tissue. Changes in the SI have been demonstrated to occur due to different pathologies and result from treatments that change the structure of the tissue being imaged.
Spectral slope
Time frame: Up to 16 months
Summarized as the maximum and/or average value over the lesion of interest (using a region of interest selection) and the liver image as a whole.
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 3 Aug 2021.
Related trials for Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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.
Aya Kamaya principal investigator
Stanford University
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 Tomography in people with Cirrhosis and Early Hepatocellular Carcinoma, 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 6 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 3 Aug 2021. 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?
Mid-band fit (time frame: Up to 16 months). The study lists 3 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 3 Aug 2021.