Liver CancerNCT02618447
4D Phase Contrast MR: Hypertrophy in Liver Cancer
A study testing 4Dimensional Phase Contrast Magnetic Resonance Angiography and Portal vein embolization in people with Liver Cancer and Cancer of the Liver, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators hypothesize that 4Dimensional Phase Contrast Magnetic Resonance Angiography (4D PC MRA) evaluation of portal venous flow predicts underlying liver function and hypertrophic potential in patients with liver cancer presenting for portal vein embolization (PVE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Cancer of the Liver
- What is being tested?
- 4Dimensional Phase Contrast Magnetic Resonance Angiography and Portal vein embolization
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2014to 4 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of malignant liver tumor
- Clinically referred for portal vein embolization
- At least 18 years of age
- Willing and able to provide informed consent
Who cannot join
- Documented or reported contrast allergy
- Unable to receive or tolerate MRI scan after evaluation of MRI screening form
- GFR (glomerular filtration rate) < 30 on labs drawn within 6 weeks of imaging.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 4D Phase Contrast MR: Validation and Evaluation of Hypertrophy in Liver Cancer
The investigators hypothesize that 4Dimensional Phase Contrast Magnetic Resonance Angiography (4D PC MRA) evaluation of portal venous flow predicts underlying liver function and hypertrophic potential in patients with liver cancer presenting for portal vein embolization (PVE). 4D PC MRA may provide a non-invasive measure of liver function that could help determine which patients could safely and successfully undergo PVE and subsequent resection of tumor. By comparing 4D PC MRA results with invasive catheter measurements the investigators will validate the flow findings. Further regression/correlation analysis with functional measures of the liver (HIDA scans), volumetrics, Doppler flow analysis, histology, and outcomes will help the investigators to determine the ability of 4D PC MRA to predict functional status and hypertrophic potential of the liver prior to PVE and hepatectomy allowing for better patient selection and reduced morbidity/mortality.
- Conditions
- Liver Cancer, Cancer of the Liver
- Being tested
- 4Dimensional Phase Contrast Magnetic Resonance Angiography, Portal vein embolization
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4Dimensional Phase Contrast Magnetic Resonance AngiographyDevice
Also called 4D PC MRA
4D PC MRA is a new non-contrast MRA technique that can measure flow of blood within vessels of interest over time.
Portal vein embolizationProcedure or surgery
Also called PRE
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: 4D phase contrast MR scan | Experimental | * Each patient will undergo a total of 3 MRI/MRA scans (lasting 30-60 minutes):
* Scan 1: Baseline (pre-portal vein embolization (PRE))
* Scan 2: Early after PVE (within 48 hours)
* Scan 3: Late after PVE (at 3-8 weeks).
* Scans 1 and 3: routine liver MR sequences with/without contrast (Gadoxetic acid, Eovist) and 4D phase contrast of the portal venous system. The 4D phase contrast sequence will be repeated twice at each time point, adding about 15-30 minutes to each scan.
* Scan 2: 4D phase contrast sequences and imaging for localization. Receives: Device: 4Dimensional Phase Contrast Magnetic Resonance Angiography; Procedure: Portal vein embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of the 4D PC MRA to measure portal venous flow findings compared to reference standards of catheter-based flow quantification
-Data from the 4D PC MRA will be compared with the reference standards of the catheter-based flow quantification to validate venous flow findings
Measured: Up to 6-8 weeks post PVE
Ability of the 4D PC MRA to measure flow velocities as compared to reference standards of the Doppler Flow Analysis
-Data from the 4D PC MRA will be compared with the reference standards of the Doppler Flow Analysis to measure flow velocities
Measured: Up to 6-8 weeks post PVE
Ability of the 4D PC MRA to measure liver function
-4D PC MRA results will be compared with invasive catheter measurements to validate the portal venous flow findings. Regression/correlation analysis will be used to analyze association between 4D PC MRA and liver function. Residuals will be tested for normality with the Shapiro-Wilk W test, and if residuals are non-normally distributed, the Spearman's rank correlation coefficient will be used
Measured: Up to 6-8 weeks post PVE
Ability of the 4D PC MRA to measure hypertrophic potential (liver function is preserved)
-Data from the 4D PC MRA will be compared with the reference standards of the HIDA scan and biopsy specimens.
Measured: Up to 6-8 weeks post PVE
Ability of the 4D PC MRA to measure flow direction of flow as compared to reference standards of the Doppler Flow Analysis
-Data from the 4D PC MRA will be compared with the reference standards of the Doppler Flow Analysis to measure direction of flow
Measured: Up to 6-8 weeks post PVE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start5 Aug 2014
- Primary completion4 Feb 2016
- Study completion4 Feb 2016
Why it stopped: Insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nael E Saad, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618447
- Sponsor's protocol ID
- 201406079
- Status last verified
- Apr 2017
- First submitted
- 18 Nov 2015
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4D Phase Contrast MR: Validation and Evaluation of Hypertrophy in Liver Cancer
- ClinicalTrials.gov ID
- NCT02618447
- Acronym / sponsor ID
- 201406079
- Conditions
- Liver Cancer, Cancer of the Liver
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient funding
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 5 Aug 2014 (actual)
- Primary completion
- 4 Feb 2016 (actual)
- Study completion
- 4 Feb 2016 (actual)
- First posted
- 1 Dec 2015 (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 investigators hypothesize that 4Dimensional Phase Contrast Magnetic Resonance Angiography (4D PC MRA) evaluation of portal venous flow predicts underlying liver function and hypertrophic potential in patients with liver cancer presenting for portal vein embolization (PVE). 4D PC MRA may provide a non-invasive measure of liver function that could help determine which patients could safely and successfully undergo PVE and subsequent resection of tumor. By comparing 4D PC MRA results with invasive catheter measurements the investigators will validate the flow findings. Further regression/correlation analysis with functional measures of the liver (HIDA scans), volumetrics, Doppler flow analysis, histology, and outcomes will help the investigators to determine the ability of 4D PC MRA to predict functional status and hypertrophic potential of the liver prior to PVE and hepatectomy allowing for better patient selection and reduced morbidity/mortality.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: 4D phase contrast MR scan | Experimental | Device: 4Dimensional Phase Contrast Magnetic Resonance Angiography, Procedure: Portal vein embolization* Each patient will undergo a total of 3 MRI/MRA scans (lasting 30-60 minutes): * Scan 1: Baseline (pre-portal vein embolization (PRE)) * Scan 2: Early after PVE (within 48 hours) * Scan 3: Late after PVE (at 3-8 weeks). * Scans 1 and 3: routine liver MR sequences with/without contrast (Gadoxetic acid, Eovist) and 4D phase contrast of the portal venous system. The 4D phase contrast sequence will be repeated twice at each time point, adding about 15-30 minutes to each scan. * Scan 2: 4D phase contrast sequences and imaging for localization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of malignant liver tumor
- Clinically referred for portal vein embolization
- At least 18 years of age
- Willing and able to provide informed consent
Key exclusion criteria (3 listed)
- Documented or reported contrast allergy
- Unable to receive or tolerate MRI scan after evaluation of MRI screening form
- GFR (glomerular filtration rate) < 30 on labs drawn within 6 weeks of imaging.
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 |
|---|---|---|
| 4Dimensional Phase Contrast Magnetic Resonance AngiographyAlso: 4D PC MRA4D PC MRA is a new non-contrast MRA technique that can measure flow of blood within vessels of interest over time. | Device | Arm 1: 4D phase contrast MR scan |
| Portal vein embolizationAlso: PRE | Procedure or surgery | Arm 1: 4D phase contrast MR scan |
Primary outcome
Ability of the 4D PC MRA to measure portal venous flow findings compared to reference standards of catheter-based flow quantification
Time frame: Up to 6-8 weeks post PVE
-Data from the 4D PC MRA will be compared with the reference standards of the catheter-based flow quantification to validate venous flow findings
Ability of the 4D PC MRA to measure flow velocities as compared to reference standards of the Doppler Flow Analysis
Time frame: Up to 6-8 weeks post PVE
-Data from the 4D PC MRA will be compared with the reference standards of the Doppler Flow Analysis to measure flow velocities
Ability of the 4D PC MRA to measure liver function
Time frame: Up to 6-8 weeks post PVE
-4D PC MRA results will be compared with invasive catheter measurements to validate the portal venous flow findings. Regression/correlation analysis will be used to analyze association between 4D PC MRA and liver function. Residuals will be tested for normality with the Shapiro-Wilk W test, and if residuals are non-normally distributed, the Spearman's rank correlation coefficient will be used
Ability of the 4D PC MRA to measure hypertrophic potential (liver function is preserved)
Time frame: Up to 6-8 weeks post PVE
-Data from the 4D PC MRA will be compared with the reference standards of the HIDA scan and biopsy specimens.
Ability of the 4D PC MRA to measure flow direction of flow as compared to reference standards of the Doppler Flow Analysis
Time frame: Up to 6-8 weeks post PVE
-Data from the 4D PC MRA will be compared with the reference standards of the Doppler Flow Analysis to measure direction of flow
Results and safety
The study was stopped early (reason given: Insufficient funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nael E Saad, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4Dimensional Phase Contrast Magnetic Resonance Angiography and Portal vein embolization in people with Liver Cancer and Cancer of the Liver, run by Washington University School of Medicine 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 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: stopped early, as of the sponsor's last update on 7 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 was stopped early (reason given: Insufficient funding). 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?
Ability of the 4D PC MRA to measure portal venous flow findings compared to reference standards of catheter-based flow quantification (time frame: Up to 6-8 weeks post PVE). The study lists 5 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 7 Apr 2017.