Chronic Liver DiseaseNCT01825213
Stratification of Patients With Chronic Liver Disease Using Multi Spectral CT
An observational study of Chronic Liver Disease and HepatoCellular Carcinoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the feasibility to stratify liver fibrosis in patients with chronic liver disease through non-invasive, spectral CT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease, HepatoCellular Carcinoma, Liver Fibrosis
- What is being tested?
- Multispectral CT of the liver
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Oct 2016
- Phase
- Observational
- 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
Study population: adult patients with newly stablished diagnosis of hepatocellular carcinoma complying with selection criteria for liver transplantation and/or biopsy.
Who may be able to join
- Adult patient with chronic liver disease undergoing CT scan for/suspicion of hepatocellular carcinoma.
- Patients should be scheduled for/or should have obtained a multiphasic MRI of the liver.
Who cannot join
- Patients < 18 years old.
- History of allergy to intravenous contrast.
- Patients at risk for contrast-induced-nephropathy,
- Pregnant patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital,
Boston, Massachusetts, 02114
About this study
The purpose of this study is to evaluate the feasibility to stratify liver fibrosis in patients with chronic liver disease through non-invasive, spectral CT.
Read the detailed description
This is a retrospective study, in which a FDA approved imaging device (spectral CT scanner) currently used for several clinical applications will be evaluated for feasibility of studying chronic liver disease (this application has not yet been validated).
Tomographic imaging has assumed a fundamental role in patients with Chronic Liver Disease (CLD) to screen patients for hepatocellular carcinoma (HCC), and, is increasingly being explored as a noninvasive alternative for characterizing liver fibrosis. The overarching goal of this study is to improve noninvasive characterization of liver fibrosis through spectral CT.
Hypothesis: concentration of iodine-based contrast agent in the liver parenchyma during the delayed phase, as measured with spectral CT imaging, increases monotonically with Ishak fibrosis score obtained from liver biopsy. This hypothesis is supported by the literature and our preliminary data, described in the references section (Lamb et al. 2015).
We will evaluate multiphase spectral CT images consisting of the arterial phase, 2-minute delayed phase, and 5-minute delayed phase. Fibrosis will be assessed on both delayed phase images, where it is assumed that any remaining contrast agent, in the liver, is due to the presence of fibrosis. This type of multiphase protocol can still be used to image CLD patients with spectral CT for HCC detection and, thus, will not interfere with liver lesion workup and evaluation.
- Being tested
- Multispectral CT of the liver
- Keywords
- Liver disease, Multi Spectral CT
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispectral CT of the liverDevice
Also called Discovery CT 750 HD, K120833
Analysis of the background liver and liver lesions will be performed on Multi Spectral CT images and compared to histology.
| Study group | Role | What they receive |
|---|---|---|
| Multispectral CT of the liver | Images of lesions and liver will be compared to histology. Receives: Device: Multispectral CT of the liver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of hepatocellular carcinoma on Multi Spectral CT
Measured: confirmation with focal biopsy and or/contrast-enhanced MRI of the liver acquired within 6 months prior to the multi spectral CT scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dushyant V. Sahani, Massachusetts General Hospital
- Investigators
- Dushyant V Sahani, MD, Principal investigator, Director of CT, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825213
- Sponsor's protocol ID
- 2013P000042
- Status last verified
- Jan 2017
- First submitted
- 2 Apr 2013
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang G, Butler A, Yu H, Campbell M. Guest editorial. Special issue on spectral CT. IEEE Trans Med Imaging. 2015 Mar;34(3):693-6. doi: 10.1109/tmi.2015.2404591. No abstract available.
PubMed 25893236Zhao W, Niu T, Xing L, Xie Y, Xiong G, Elmore K, Zhu J, Wang L, Min JK. Using edge-preserving algorithm with non-local mean for significantly improved image-domain material decomposition in dual-energy CT. Phys Med Biol. 2016 Feb 7;61(3):1332-51. doi: 10.1088/0031-9155/61/3/1332.
PubMed 26796948Breguet R, Ronot M, Goossens N, Hansen C, Giostra E, Majno P, Becker CD, Spahr L, Terraz S. Liver volume is a prognostic indicator for clinical outcome of patients with alcoholic hepatitis. Abdom Radiol (NY). 2017 Feb;42(2):460-467. doi: 10.1007/s00261-016-0892-7.
PubMed 27604894Lestra T, Mule S, Millet I, Carsin-Vu A, Taourel P, Hoeffel C. Applications of dual energy computed tomography in abdominal imaging. Diagn Interv Imaging. 2016 Jun;97(6):593-603. doi: 10.1016/j.diii.2015.11.018. Epub 2016 Mar 15.
PubMed 26993967Patino M, Prochowski A, Agrawal MD, Simeone FJ, Gupta R, Hahn PF, Sahani DV. Material Separation Using Dual-Energy CT: Current and Emerging Applications. Radiographics. 2016 Jul-Aug;36(4):1087-105. doi: 10.1148/rg.2016150220.
PubMed 27399237Daginawala N, Li B, Buch K, Yu H, Tischler B, Qureshi MM, Soto JA, Anderson S. Using texture analyses of contrast enhanced CT to assess hepatic fibrosis. Eur J Radiol. 2016 Mar;85(3):511-7. doi: 10.1016/j.ejrad.2015.12.009. Epub 2015 Dec 17.
PubMed 26860661De Cecco CN, Boll DT, Bolus DN, Foley WD, Kaza RK, Morgan DE, Rofsky NM, Sahani DV, Schoepf UJ, Shuman WP, Siegel MJ, Vrtiska TJ, Yeh BM, Berland LL. White Paper of the Society of Computed Body Tomography and Magnetic Resonance on Dual-Energy CT, Part 4: Abdominal and Pelvic Applications. J Comput Assist Tomogr. 2017 Jan;41(1):8-14. doi: 10.1097/RCT.0000000000000546.
PubMed 27824670
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stratification of Patients With Chronic Liver Disease Using Multi Spectral CT
- ClinicalTrials.gov ID
- NCT01825213
- Acronym / sponsor ID
- 2013P000042
- Keywords
- Liver disease, Multi Spectral CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 5 Apr 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.
The purpose of this study is to evaluate the feasibility to stratify liver fibrosis in patients with chronic liver disease through non-invasive, spectral CT.
Detailed description
This is a retrospective study, in which a FDA approved imaging device (spectral CT scanner) currently used for several clinical applications will be evaluated for feasibility of studying chronic liver disease (this application has not yet been validated).
Tomographic imaging has assumed a fundamental role in patients with Chronic Liver Disease (CLD) to screen patients for hepatocellular carcinoma (HCC), and, is increasingly being explored as a noninvasive alternative for characterizing liver fibrosis. The overarching goal of this study is to improve noninvasive characterization of liver fibrosis through spectral CT.
Hypothesis: concentration of iodine-based contrast agent in the liver parenchyma during the delayed phase, as measured with spectral CT imaging, increases monotonically with Ishak fibrosis score obtained from liver biopsy. This hypothesis is supported by the literature and our preliminary data, described in the references section (Lamb et al. 2015).
We will evaluate multiphase spectral CT images consisting of the arterial phase, 2-minute delayed phase, and 5-minute delayed phase. Fibrosis will be assessed on both delayed phase images, where it is assumed that any remaining contrast agent, in the liver, is due to the presence of fibrosis. This type of multiphase protocol can still be used to image CLD patients with spectral CT for HCC detection and, thus, will not interfere with liver lesion workup and evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multispectral CT of the liver | – | Device: Multispectral CT of the liverImages of lesions and liver will be compared to histology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients with newly stablished diagnosis of hepatocellular carcinoma complying with selection criteria for liver transplantation and/or biopsy.
Key inclusion criteria (2 listed)
- Adult patient with chronic liver disease undergoing CT scan for/suspicion of hepatocellular carcinoma.
- Patients should be scheduled for/or should have obtained a multiphasic MRI of the liver.
Key exclusion criteria (4 listed)
- Patients < 18 years old.
- History of allergy to intravenous contrast.
- Patients at risk for contrast-induced-nephropathy,
- Pregnant patients.
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 |
|---|---|---|
| Multispectral CT of the liverAlso: Discovery CT 750 HD, K120833Analysis of the background liver and liver lesions will be performed on Multi Spectral CT images and compared to histology. | Device | Multispectral CT of the liver |
Primary outcome
Detection of hepatocellular carcinoma on Multi Spectral CT
Time frame: confirmation with focal biopsy and or/contrast-enhanced MRI of the liver acquired within 6 months prior to the multi spectral CT scan.
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 17 Apr 2017.
- Background: PubMed 25893236Wang G, Butler A, Yu H, Campbell M. Guest editorial. Special issue on spectral CT. IEEE Trans Med Imaging. 2015 Mar;34(3):693-6. doi: 10.1109/tmi.2015.2404591. No abstract available.
- Background: PubMed 26796948Zhao W, Niu T, Xing L, Xie Y, Xiong G, Elmore K, Zhu J, Wang L, Min JK. Using edge-preserving algorithm with non-local mean for significantly improved image-domain material decomposition in dual-energy CT. Phys Med Biol. 2016 Feb 7;61(3):1332-51. doi: 10.1088/0031-9155/61/3/1332.
- Background: PubMed 27604894Breguet R, Ronot M, Goossens N, Hansen C, Giostra E, Majno P, Becker CD, Spahr L, Terraz S. Liver volume is a prognostic indicator for clinical outcome of patients with alcoholic hepatitis. Abdom Radiol (NY). 2017 Feb;42(2):460-467. doi: 10.1007/s00261-016-0892-7.
- Background: PubMed 26993967Lestra T, Mule S, Millet I, Carsin-Vu A, Taourel P, Hoeffel C. Applications of dual energy computed tomography in abdominal imaging. Diagn Interv Imaging. 2016 Jun;97(6):593-603. doi: 10.1016/j.diii.2015.11.018. Epub 2016 Mar 15.
- Background: PubMed 27399237Patino M, Prochowski A, Agrawal MD, Simeone FJ, Gupta R, Hahn PF, Sahani DV. Material Separation Using Dual-Energy CT: Current and Emerging Applications. Radiographics. 2016 Jul-Aug;36(4):1087-105. doi: 10.1148/rg.2016150220.
- Background: PubMed 26860661Daginawala N, Li B, Buch K, Yu H, Tischler B, Qureshi MM, Soto JA, Anderson S. Using texture analyses of contrast enhanced CT to assess hepatic fibrosis. Eur J Radiol. 2016 Mar;85(3):511-7. doi: 10.1016/j.ejrad.2015.12.009. Epub 2015 Dec 17.
- Background: PubMed 27824670De Cecco CN, Boll DT, Bolus DN, Foley WD, Kaza RK, Morgan DE, Rofsky NM, Sahani DV, Schoepf UJ, Shuman WP, Siegel MJ, Vrtiska TJ, Yeh BM, Berland LL. White Paper of the Society of Computed Body Tomography and Magnetic Resonance on Dual-Energy CT, Part 4: Abdominal and Pelvic Applications. J Comput Assist Tomogr. 2017 Jan;41(1):8-14. doi: 10.1097/RCT.0000000000000546.
- Individual participant dataSharing planned: No
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Liver Diseases
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.
Dushyant V Sahani, MD principal investigator
Director of CT, Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Disease and HepatoCellular Carcinoma, run by Massachusetts General Hospital 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 4 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 17 Apr 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?
Detection of hepatocellular carcinoma on Multi Spectral CT (time frame: confirmation with focal biopsy and or/contrast-enhanced MRI of the liver acquired within 6 months prior to the multi spectral CT scan.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01825213, which also lists 7 linked publications.
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 17 Apr 2017.