Hepatocellular CarcinomaNCT01871545
Evaluation of Liver Cancer With Magnetic Resonance Imaging (MRI)
A study testing Magnetic Resonance Imaging in people with Hepatocellular Carcinoma and HCC, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The incidence of hepatocellular carcinoma (HCC) has recently increased in the United States. Although imaging plays a major role in HCC screening and staging, the possibility of predicting HCC tumor grade, aggressiveness, angiogenesis and hypoxia with imaging are unmet needs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma, HCC
- What is being tested?
- Magnetic Resonance Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 2 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Study group
- Patients diagnosed with HCC, who will undergo resection or transplantation within 6 months, as part of routine clinical care and patients diagnosed with unresectable HCC
- 18 years of age and older
- Patient is able to give informed consent for this study
- Control group
- Healthy volunteers 18 years of age and older
- Subject is able to give informed consent for this study
Who cannot join
- Age less than 18 years
- Unable or unwilling to give informed consent
- Contra-indications to MRI:
- Electrical implants such as cardiac pacemakers or perfusion pumps
- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
- Ferromagnetic objects such as jewelry or metal clips in clothing
- Pregnant subjects
- Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 11103
About this study
Official title: Evaluation of HCC Response to Systemic Therapy With Quantitative MRI
The incidence of hepatocellular carcinoma (HCC) has recently increased in the United States. Although imaging plays a major role in HCC screening and staging, the possibility of predicting HCC tumor grade, aggressiveness, angiogenesis and hypoxia with imaging are unmet needs. In addition, new antiangiogenic drugs now available to treat advanced HCC necessitate the use of new imaging criteria beyond size. The investigators would like to develop and validate non-invasive magnetic resonance imaging (MRI) methods based on advanced diffusion-weighted imaging (DWI), MR Elastography, BOLD (blood oxygen level dependent) MRI and perfusion-weighted imaging (PWI, using gadolinium contrast) to be used as non-invasive markers of major histopathologic features of HCC, and to predict and assess early response of HCC to systemic therapy. The investigators also would like to develop quality control tools to improve the quality and decrease variability of quantitative MRI metrics. These techniques combined could represent non-invasive correlates of histologic findings in HCC, could enable individualized therapy, and provide prognosis in patients with HCC.
Read the detailed description
The incidence of hepatocellular carcinoma (HCC) has recently increased in the US mostly due to an increase in chronic hepatitis C infection. Angiogenesis is critical for the growth and metastatic progression of HCC. With the development of new antiangiogenic drugs such as sorafenib, imaging methods to predict and assess therapeutic response beyond changes in size become critical. However, validated imaging methods to predict and assess early HCC response to targeted agents are lacking.
In this study, the investigators would like to develop quantitative MRI methods interrogating different features of HCC tumor biology and pathology, including tumor cellularity, grade, angiogenesis and hypoxia. The investigators propose a multiparametric approach combining advanced DWI (IVIM: intravoxel incoherent motion diffusion measuring perfusion fraction and true diffusion coefficient), DCE-MRI (dynamic contrast-enhanced MRI, which measures arterial and portal flow, mean transit time, blood volume and distribution volume), and BOLD MRI using oxygen or carbogen challenge. This protocol will be performed in patients with HCC undergoing hepatic resection. Routine and advanced histopathologic methods will be performed (tumor grade, CK19 expression, presence of microvascular invasion, VEGF expression, microvessel density, HIF 1-alpha expression). MRI metrics will be correlated with histopathologic metrics.
The first portion of the proposal involves the development of a QC algorithm assessing MR data quality and test-retest. The investigators will propose solutions to improve data acquisition and processing. The last 2 years of the study will be dedicated to a prospective randomized study comparing Yttrium 90 radioembolization to sorafenib, assessing the role of baseline MRI metrics and early changes (at 2 weeks) in these metrics as markers of tumor response and time to progression in patients with unresectable HCC.
- Conditions
- Hepatocellular Carcinoma, HCC
- Being tested
- Magnetic Resonance Imaging
- Keywords
- hepatocellular carcinoma, HCC, liver cancer, liver disease, magnetic resonance imaging, MRI
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDevice
Also called MRI
Magnetic Resonance Imaging is a radiation free non invasive technique using magnetic radiofrequency waves to image the body. In this study, the research team would like to investigate the possibility of providing functional information on aggressiveness, vascularity and oxygen uptake in liver cancer tumors.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Resonance Imaging | Experimental | dynamic contrast-enhanced MRI measuring arterial and portal flow Receives: Device: Magnetic Resonance Imaging |
| Healthy Controls | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
SubStudy 1: Apparent Diffusion Coefficient (ADC)
Tumor diffusion (apparent diffusion coefficient) measured with diffusion-weighted imaging sequence
Measured: Day 1
SubStudy 1: Total Tumor Perfusion (Ft)
Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast
Measured: Day 1
SubStudy 1: Tumor Arterial Perfusion Fraction (ART)
Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast
Measured: Day 1
SubStudy 1: Tumor Mean Transit Time (MTT)
Tumor mean transit time (MTT) of contrast agent. Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast
Measured: Day 1
SubStudy 1: Tumor Distribution Volume (DV)
Tumor distribution volume (DV) of contrast agent. Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast
Measured: Day 1
SubStudy 1: Oxygen Uptake
Oxygen uptake measured with T2* and T1-weighted imaging
Measured: Day 1
SubStudy 1: Percent Change in Oxygen Uptake
Oxygen uptake measured with T2* and T1-weighted imaging. Oxygen uptake (% change pre and post O2 administration) calculated by Liver ΔR2*=100 x (R2* post O2-R2* pre O2)/R2* pre O2. The healthy participants breathed 100% medical O2 through a mask for 10 min., and were imaged before and after O2 administration with the MRI methods that are sensitive to oxygen uptake in tumors.
Measured: Day 1, pre-oxygen administration and 10 min. post-oxygen administration
SubStudy 2: ADC
Tumor diffusion measured with diffusion-weighted imaging sequence. In diffusion weighted MR imaging (DWI), the signal is proportional to the Brownian motion diffusion of free water protons in tissues. Deposition of collagen in tissue (as in fibrotic disease), or cellularity in tumors act as impediments to free water diffusion. Using different mathematical models, the degree of diffusion can be quantified from the MRI signal, to provide information on diffusion restriction due to disease. From mono exponential fit of diffusion signal, one can obtain the apparent diffusion coefficient (ADC). However, this coefficient reflects free water proton diffusion, as well as transport of water protons in the capillary vessels (capillary perfusion).
Measured: baseline and 6 weeks after Y90
SubStudy 2: Diffusion Coefficient D
Tumor diffusion measured with diffusion-weighted imaging sequence. To separate the diffusion effect from capillary perfusion, a bi-exponential model is used, which provides 3 coefficients: one is the true diffusion coefficient D, reflecting free water proton diffusion.
Measured: baseline and 6 weeks after Y90
SubStudy 2: Pseudodiffusion Coefficient D*
Tumor diffusion measured with diffusion-weighted imaging sequence. To separate the diffusion effect from capillary perfusion, a bi-exponential model is used, which provides 3 coefficients: one is the pseudo-diffusion coefficient D*, affected by free diffusion and capillary perfusion.
Measured: baseline and 6 weeks after Y90
SubStudy 2: Perfusion Fraction (PF)
Tumor diffusion measured with diffusion-weighted imaging sequence. To separate the diffusion effect from capillary perfusion, a bi-exponential model is used, which provides 3 coefficients: one is the perfusion fraction PF, which reflects how much the diffusion-weighted signal is affected by capillary perfusion. PF is a measure of vascularity in the tissue.
Measured: baseline and 6 weeks after Y90
Secondary outcomes (6)
SubStudy 2: Total Tumor Perfusion (Ft)
Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast
Measured: baseline and 6 weeks after Y90
SubStudy 2: Tumor Arterial Perfusion Fraction (ART)
Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast
Measured: baseline and 6 weeks after Y90
SubStudy 2: Tumor Mean Transit Time (MTT) of Contrast Agent
Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast
Measured: baseline and 6 weeks after Y90
SubStudy 2: Extravascular Extracellular Volume ve
Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast. Extravascular extracellular volume fraction ve (%) - represents the portion of tissue occupied by the extravascular extracellular volume (interstitial space), in which MRI contrast agent can distribute.
Measured: baseline and 6 weeks after Y90
Substudy 2: Tumor Stiffness
measured with magnetic resonance elastography
Measured: baseline and 6 weeks after Y90
Tumor Response
Tumor response to treatment is evaluated clinically by radiologists according to RECIST and modified RECIST criteria, by which the diameter of the tumor portion that enhances (lights up on imaging) after administration of gadolinium contrast agent is measured before and after treatment. The response is not reported as diameter or diameter difference in mm, but rather as a qualitative variable: complete response, partial response, stable disease and progressive disease. Complete response means no enhancing tumor regions after treatment (i.e. complete tumor necrosis, no more vascular regions of the tumor that take up contrast), partial response is a decrease in the diameter of the enhancing region, stable disease is unchanged diameter, and progressive disease is an increase in the diameter of the enhancing region after treatment.
Measured: 6 weeks and 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJun 2013
- Primary completion2 Feb 2018
- Study completion2 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bachir Taouli, Icahn School of Medicine at Mount Sinai
- Investigators
- Bachir Taouli, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871545
- Sponsor's protocol ID
- GCO 12-0214
- Status last verified
- Jun 2020
- First submitted
- 4 Jun 2013
- Last updated
- 9 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of HCC Response to Systemic Therapy With Quantitative MRI
- ClinicalTrials.gov ID
- NCT01871545
- Acronym / sponsor ID
- GCO 12-0214
- Conditions
- Hepatocellular Carcinoma, HCC
- Keywords
- hepatocellular carcinoma, HCC, liver cancer, liver disease, magnetic resonance imaging, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 2 Feb 2018 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Posted 9 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incidence of hepatocellular carcinoma (HCC) has recently increased in the United States. Although imaging plays a major role in HCC screening and staging, the possibility of predicting HCC tumor grade, aggressiveness, angiogenesis and hypoxia with imaging are unmet needs. In addition, new antiangiogenic drugs now available to treat advanced HCC necessitate the use of new imaging criteria beyond size. The investigators would like to develop and validate non-invasive magnetic resonance imaging (MRI) methods based on advanced diffusion-weighted imaging (DWI), MR Elastography, BOLD (blood oxygen level dependent) MRI and perfusion-weighted imaging (PWI, using gadolinium contrast) to be used as non-invasive markers of major histopathologic features of HCC, and to predict and assess early response of HCC to systemic therapy. The investigators also would like to develop quality control tools to improve the quality and decrease variability of quantitative MRI metrics. These techniques combined could represent non-invasive correlates of histologic findings in HCC, could enable individualized therapy, and provide prognosis in patients with HCC.
Detailed description
The incidence of hepatocellular carcinoma (HCC) has recently increased in the US mostly due to an increase in chronic hepatitis C infection. Angiogenesis is critical for the growth and metastatic progression of HCC. With the development of new antiangiogenic drugs such as sorafenib, imaging methods to predict and assess therapeutic response beyond changes in size become critical. However, validated imaging methods to predict and assess early HCC response to targeted agents are lacking.
In this study, the investigators would like to develop quantitative MRI methods interrogating different features of HCC tumor biology and pathology, including tumor cellularity, grade, angiogenesis and hypoxia. The investigators propose a multiparametric approach combining advanced DWI (IVIM: intravoxel incoherent motion diffusion measuring perfusion fraction and true diffusion coefficient), DCE-MRI (dynamic contrast-enhanced MRI, which measures arterial and portal flow, mean transit time, blood volume and distribution volume), and BOLD MRI using oxygen or carbogen challenge. This protocol will be performed in patients with HCC undergoing hepatic resection. Routine and advanced histopathologic methods will be performed (tumor grade, CK19 expression, presence of microvascular invasion, VEGF expression, microvessel density, HIF 1-alpha expression). MRI metrics will be correlated with histopathologic metrics.
The first portion of the proposal involves the development of a QC algorithm assessing MR data quality and test-retest. The investigators will propose solutions to improve data acquisition and processing. The last 2 years of the study will be dedicated to a prospective randomized study comparing Yttrium 90 radioembolization to sorafenib, assessing the role of baseline MRI metrics and early changes (at 2 weeks) in these metrics as markers of tumor response and time to progression in patients with unresectable HCC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic Resonance Imaging | Experimental | Device: Magnetic Resonance Imagingdynamic contrast-enhanced MRI measuring arterial and portal flow |
| Healthy Controls | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Study group
- Patients diagnosed with HCC, who will undergo resection or transplantation within 6 months, as part of routine clinical care and patients diagnosed with unresectable HCC
- 18 years of age and older
- Patient is able to give informed consent for this study
- Control group
Key exclusion criteria (8 listed)
- Age less than 18 years
- Unable or unwilling to give informed consent
- Contra-indications to MRI:
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 |
|---|---|---|
| Magnetic Resonance ImagingAlso: MRIMagnetic Resonance Imaging is a radiation free non invasive technique using magnetic radiofrequency waves to image the body. In this study, the research team would like to investigate the possibility of providing functional information on aggressiveness, vascularity and oxygen uptake in liver cancer tumors. | Device | Magnetic Resonance Imaging |
Primary outcome
SubStudy 1: Apparent Diffusion Coefficient (ADC)
Time frame: Day 1
Tumor diffusion (apparent diffusion coefficient) measured with diffusion-weighted imaging sequence
SubStudy 1: Total Tumor Perfusion (Ft)
Time frame: Day 1
Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast
SubStudy 1: Tumor Arterial Perfusion Fraction (ART)
Time frame: Day 1
Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast
SubStudy 1: Tumor Mean Transit Time (MTT)
Time frame: Day 1
Tumor mean transit time (MTT) of contrast agent. Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast
SubStudy 1: Tumor Distribution Volume (DV)
Time frame: Day 1
Tumor distribution volume (DV) of contrast agent. Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast
SubStudy 1: Oxygen Uptake
Time frame: Day 1
Oxygen uptake measured with T2* and T1-weighted imaging
SubStudy 1: Percent Change in Oxygen Uptake
Time frame: Day 1, pre-oxygen administration and 10 min. post-oxygen administration
Oxygen uptake measured with T2* and T1-weighted imaging. Oxygen uptake (% change pre and post O2 administration) calculated by Liver ΔR2*=100 x (R2* post O2-R2* pre O2)/R2* pre O2. The healthy participants breathed 100% medical O2 through a mask for 10 min., and were imaged before and after O2 administration with the MRI methods that are sensitive to oxygen uptake in tumors.
SubStudy 2: ADC
Time frame: baseline and 6 weeks after Y90
Tumor diffusion measured with diffusion-weighted imaging sequence. In diffusion weighted MR imaging (DWI), the signal is proportional to the Brownian motion diffusion of free water protons in tissues. Deposition of collagen in tissue (as in fibrotic disease), or cellularity in tumors act as impediments to free water diffusion. Using different mathematical models, the degree of diffusion can be quantified from the MRI signal, to provide information on diffusion restriction due to disease. From mono exponential fit of diffusion signal, one can obtain the apparent diffusion coefficient (ADC). However, this coefficient reflects free water proton diffusion, as well as transport of water protons in the capillary vessels (capillary perfusion).
SubStudy 2: Diffusion Coefficient D
Time frame: baseline and 6 weeks after Y90
Tumor diffusion measured with diffusion-weighted imaging sequence. To separate the diffusion effect from capillary perfusion, a bi-exponential model is used, which provides 3 coefficients: one is the true diffusion coefficient D, reflecting free water proton diffusion.
SubStudy 2: Pseudodiffusion Coefficient D*
Time frame: baseline and 6 weeks after Y90
Tumor diffusion measured with diffusion-weighted imaging sequence. To separate the diffusion effect from capillary perfusion, a bi-exponential model is used, which provides 3 coefficients: one is the pseudo-diffusion coefficient D*, affected by free diffusion and capillary perfusion.
SubStudy 2: Perfusion Fraction (PF)
Time frame: baseline and 6 weeks after Y90
Tumor diffusion measured with diffusion-weighted imaging sequence. To separate the diffusion effect from capillary perfusion, a bi-exponential model is used, which provides 3 coefficients: one is the perfusion fraction PF, which reflects how much the diffusion-weighted signal is affected by capillary perfusion. PF is a measure of vascularity in the tissue.
6 secondary outcomes
SubStudy 2: Total Tumor Perfusion (Ft)
Time frame: baseline and 6 weeks after Y90
SubStudy 2: Tumor Arterial Perfusion Fraction (ART)
Time frame: baseline and 6 weeks after Y90
SubStudy 2: Tumor Mean Transit Time (MTT) of Contrast Agent
Time frame: baseline and 6 weeks after Y90
SubStudy 2: Extravascular Extracellular Volume ve
Time frame: baseline and 6 weeks after Y90
Substudy 2: Tumor Stiffness
Time frame: baseline and 6 weeks after Y90
Tumor Response
Time frame: 6 weeks and 6-12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bachir Taouli, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging in people with Hepatocellular Carcinoma and HCC, run by Icahn School of Medicine at Mount Sinai 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 7 inclusion and 8 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 9 Jul 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
SubStudy 1: Apparent Diffusion Coefficient (ADC) (time frame: Day 1). The study lists 11 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 9 Jul 2020.