Liver CancerHepQuantNCT06899152
HepQuant: Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer
A study testing HepQuant DuO and Multiparametric MRI Scans in people with Liver Cancer and Hepatocellular Carcinoma, run by Montefiore Medical Center at 1 site in United States.
Trial summary
This is a pilot and feasibility study assessing the role of quantitative multiparametric MRI and blood-based biomarkers for the measurement of liver function in patients receiving radiation therapy for liver cancer, including hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver metastases regardless of primary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Hepatocellular Carcinoma, Hepatocellular Cancer
- What is being tested?
- HepQuant DuO and Multiparametric MRI Scans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2025to Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age > 18
- Patient has the psychological ability and general health needed to provide informed consent, completion of study requirements, and required follow-up
- Patient provides study-specific informed consent prior to study entry
- All primary histologies (Hepatocellular carcinoma or Cholangiocarcinoma) as well as hepatic metastases are eligible
- Prior history of radiation therapy (external beam or radioembolization) is allowed, with no limit to the number of prior courses of radiation therapy
- Any number of lesions (with no size limit) of pathologically documented (histologically or cytologically) or radiographically proven tumor/metastasis that are being targeted
Show all 9Show fewer
- Prior history of liver resection, transarterial chemoembolization (TACE), or ablation are allowed with no restriction on number of prior therapies, or time from current study registration
- Prior history of chemotherapy, immunotherapy, or targeted biological therapy is allowed
- Concurrent enrollment on other prospective registry or treatment intention trials is allowed
Who cannot join
- Pregnant or breast-feeding females
- Subjects with history of claustrophobia impacting ability to perform MRI during the study
- Subjects who fulfill any of the contraindications for MRI; examples include any ferromagnetic material, any metallic shrapnel or fragments or implanted electronic devices contained within the body or metal-containing tattoos
- Unable to participate in MR assessments due to physical limitations of equipment tolerances (MRI bore size and/or weight limit)
- Any person unable to lie still within the environment of the MRI scanner or maintain a breath hold for the required period to acquire images
- Known history or suspected hypersensitivity to human serum albumin, or its preparations
Show all 10Show fewer
- Subjects with extensive resection of large segments of small intestine (short gut) or severe gastroparesis (e.g., diabetic or medication-induced gastroparesis)
- Subjects on either a non-selective beta blocker (propranolol, nadolol), or an angiotensin converting enzyme (ACE) inhibitor, or angiotensin receptor blocker (ARB) who are unwilling or unable to delay taking their normal dose the morning of their testing
- Subjects who are allergic to any ingredient in the formulations or components in the HepQuant SHUNT DuO kit including the human serum albumin (HSA) or cholate compounds (theoretical - none yet reported)
- Subjects unwilling or unable to fast for at least 5 hours. Fasting means no intake of food or food supplements, including fiber preparations or biosimilars; or any preparations or resins (cholestyramine, colestipol, colesevelam) that might act within the gut lumen to bind the orally administered d4-cholate in the HepQuant test.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rikin Gandhi contact
United States1 site, 1 recruiting
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Rikin Gandhi, rgandhi@montefiore.org
Jill Salvi, 857-399-5039, jsalvi@montefiore.org
About this study
Official title: HepQuant: Pilot Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer
This is a pilot and feasibility study assessing the role of quantitative multiparametric MRI and blood-based biomarkers for the measurement of liver function in patients receiving radiation therapy for liver cancer, including hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver metastases regardless of primary histology, that are undergoing photon radiation either in the de-novo or re-irradiation setting. The goal of this study is to prospectively evaluate the feasibility of using quantitative multiparametric MRI to monitor liver function at baseline and following liver radiation therapy.
Read the detailed description
Historically, the role of fractionated liver radiation therapy (RT) has been limited because of the potential for developing fatal radiation-induced liver disease (RILD), particularly in patients who already have poor liver function due to cirrhosis. Classic RILD generally occurs within 4 months following radiotherapy to the liver and consists of symptoms including fatigue, right upper quadrant pain, ascites, anicteric hepatomegaly, and elevation of liver enzymes especially alkaline phosphatase.
Technical advances in the delivery of RT, particularly using stereotactic body radiotherapy (SBRT) and proton therapy with respiratory gating and image guidance, have facilitated the safe use of radiation dose escalation in unresectable liver cancers. SBRT is a promising and attractive option for HCC patients with cirrhosis. Previous reported experiences have been largely kept to Child-Pugh (CP) A patients with significant liver reserves. The 1 to 2-year local control rate for CP A patients with early-stage tumor have generally been reported around 80-90%. Toxicities rates have also been acceptable with no classic RILD or grade 4 or 5 treatment related toxicities seen 3 months after SBRT. This impressive toxicity result is likely due to keeping with strict dosimetric constraints for the normal liver tissue. Dosimetric parameters reported in literature indicated mean liver disease (MLD) and V20 to be a significant predictor of RILD and elevated liver enzymes in CP A patients with primary HCC.
While there are no overt liver toxicities in CP A patients with primary liver cancer, 10 to 30% of patients will experience a decline in liver function 3 months after SBRT even without disease progression based on the referenced literature. Pre-treatment CP A6 has an increased risk of liver function decline when compared to CP A5. In addition, the tumor volume was also a significant predictor of liver function decline after SBRT.
Patients with CP B or C and primary HCC are more likely to experience liver toxicities as defined by worsening liver function. Dosimetric parameters to predict for fatal RILD for this group has also remained elusive. Yet, it is this particular group of patients that have the worst outcome due to limited treatment options as a result of poor liver reserve to tolerate currently available treatments. The median survival for patients with Child-Pugh B or C HCC treated with best supportive care or sorafenib is approximately 4-5 months according to the literature. Limited institutional experiences have shown that local treatment of these patients with SBRT can potentially improve survival; however, this also comes at a cost of significant potential toxicity. Current reported data are limited, but they do show that patients can experience liver function decline as early as 3 months.
The published experience with SBRT in the treatment of HCC clearly demonstrates a relationship of the underlying degree of hepatic impairment to risk for liver toxicity. However, the data also clearly demonstrate that CP class or score is insufficient to define risk or to monitor treatment effects. The proposed study will use blood-based biomarkers coupled with quantitative imaging (LiverMultiScan™) to fully characterize the effect of SBRT on the liver and the liver cancer.
In vivo Multiparametric MR imaging (mpMRI) is well established at quantifying measures of liver health in patients with liver disease and pre-clinical models of liver disease. In patients with pre-existing/co-existing parenchymal liver disease and liver tumors (primary or secondary), mpMRI can be used to assess the health of the parenchyma and the anatomical and tissue characteristics of the tumor. This allows for decision-making to be based on the health of the liver and the resectability of the tumor. Initial data suggests that this approach can predict which operations will carry higher risk and cost, measured by length of stay in hospital after surgery.
A more sensitive laboratory measure that is currently available in the U.S. as a Laboratory Developed Test (LDT) to measure liver function and will be used in this study as an investigational assay, is the HepQuant DuO test. It measures cholate hepatic uptake from portal circulation and estimates hepatic uptake from systemic circulation to calculate degree of portosystemic shunting as well as hepatic function using the disease severity index (DSI). Both of these measures have been shown to correlate with severity of chronic liver disease and in studies detected and measured the severity and progression of disease and the response to treatments. The HepQuant DuO test is done by oral administration of unconjugated cholate and collection of two serum samples up to 60 minutes after administration. HepQuant DuO may offer a unique capability to assesses liver functional impairment across the spectrum of injury and fibrosis in patients undergoing radiation therapy to better predict clinical outcomes and risk of liver function deterioration.
- Conditions
- Liver Cancer, Hepatocellular Carcinoma, Hepatocellular Cancer, Cholangiocarcinoma, Liver Metastases
- Being tested
- HepQuant DuO, Multiparametric MRI Scans
- Keywords
- Blood-based biomarkers, Quantitative MR imaging, Radiotherapy
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepQuant DuODiagnostic test
HepQuant DuO is a quantitative liver function test. It assesses cholate uptake, a liver specific function. Cholate is a naturally occurring substance that is cleared by the liver. Cholate uptake reflects the health of liver cells.
Multiparametric MRI ScansOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Multiparametric MRI scans and HepQuant Duo Test | Experimental | Not described Receives: Diagnostic Test: HepQuant DuO; Other: Multiparametric MRI Scans |
| Multiparametric MRI scans only | Active comparator | Not described Receives: Other: Multiparametric MRI Scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Quantitative MRI
Feasibility will be determined by assessing the proportion/percentage of participants who complete at least 2 quantitative multiparametric MRI scans following study enrollment. The proportion/percentage of patients will be summarized by study arm using basic descriptive statistics and a Clopper-Pearson 95% exact confidence interval will be determined.
Measured: Approximately 3 months
Secondary outcomes (4)
Change in Disease Severity Index (DSI) score
Change in DSI scores from baseline will be evaluated using the HepQuant DuO test. The HepQuant DuO test measures the liver's ability to clear cholate from the blood using the Disease Severity Index (DSI). The DSI is a single score calculation that incorporates measures of both hepatocyte function and portal circulation and is calculated by indexing a patient's hepatic filtration rate (HFR) against maximum HFR and generates a liver DSI score ranging from 0 (no hepatic disease) to 50 (severe hepatic disease) such that increased DSI scores are correlated with worsening liver function and disease severity and progression. For purposes of this study change in DSI score from baseline will be summarized using basic descriptive statistics and will be examined using a Wilcoxon Sign rank test.
Measured: From baseline to 3 months post-SBRT
Predictive ability of LiverMultiScan
The ability of the LiverMultiScan to predict the risk of non-classic RILD will be evaluated. The pre-SBRT liver health assessment score will be calculated by measuring the Future Liver Remnant volume outside the 50% radiation isodose line weighted by the liver cT1 value. MRI images will be post-processed using LiverMultiScan, which provides a multiparametric quantitative map of a region of interest in the liver including characterization of the underlying liver fibroinflammation as reported by a corrected T1 (cT1) value, which will be measured and reported in milliseconds (ms). The likelihood of non-classic RILD based on the cT1 value will be assessed using multivariable logistic regression.
Non-classic RILD will be defined as either worsening of Child-Pugh Score by >=2 points (overall range: 5-15 points) at 6 months following SBRT or an elevated aminotransferase (ALT or AST) level > 5 times the upper limit of normal or baseline value within 90 days of completion of SBRT.
Measured: 6 months post-SBRT
Change in Total Liver Volume
Change in total liver volume from pre-SBRT treatment at baseline will be evaluated using Gd-EOB-DTPA enhanced MRI of the abdomen at the specified timeframes to assess the impact of radiotherapy. Mean changes in total liver volume (in mL or cm^3) will be assessed using the MRI software image analysis and summarized by study arm and data will be analyzed using linear mixed-effects models. Increases in liver volume are correlated to more favorable outcomes.
Measured: From baseline to 3 months, 6 months, 9 months and 12 months post-SBRT
Change in volume of non-irradiated and irradiated liver lobes
Change in volume of non-irradiated and irradiated liver lobes, from pre-SBRT treatment at baseline will be evaluated using Gd-EOB-DTPA enhanced MRI of the abdomen at the specified timeframes to assess the impact of radiotherapy. Mean changes in the volume of non-irradiated and irradiate lobes (in mL or cm^3) will be assessed using the MRI software image analysis and summarized by study arm and data will be analyzed using linear mixed-effects models. Increases in liver lobe volume are correlated to more favorable outcomes.
Measured: From baseline to 3 months, 6 months, 9 months and 12 months post-SBRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start16 Jul 2025
- Primary completionJul 2031 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- HepQuant, LLC, Perspectum
- Responsible party
- Sponsor
- Investigators
- Rafi Kabarriti, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899152
- Sponsor's protocol ID
- 2025-16581
- Other IDs
- 2025
- Acronym
- HepQuant
- Status last verified
- Aug 2026
- First submitted
- 21 Mar 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Russell AH, Clyde C, Wasserman TH, Turner SS, Rotman M. Accelerated hyperfractionated hepatic irradiation in the management of patients with liver metastases: results of the RTOG dose escalating protocol. Int J Radiat Oncol Biol Phys. 1993 Sep 1;27(1):117-23. doi: 10.1016/0360-3016(93)90428-x.
PubMed 8365932Ben-Josef E, Lawrence TS. Radiotherapy for unresectable hepatic malignancies. Semin Radiat Oncol. 2005 Oct;15(4):273-8. doi: 10.1016/j.semradonc.2005.04.006.
PubMed 16183481Dawson LA, Guha C. Hepatocellular carcinoma: radiation therapy. Cancer J. 2008 Mar-Apr;14(2):111-6. doi: 10.1097/PPO.0b013e31816a0e80.
PubMed 18391616Tse RV, Guha C, Dawson LA. Conformal radiotherapy for hepatocellular carcinoma. Crit Rev Oncol Hematol. 2008 Aug;67(2):113-23. doi: 10.1016/j.critrevonc.2008.01.005. Epub 2008 Mar 4.
PubMed 18308583Ohri N, Tome WA, Mendez Romero A, Miften M, Ten Haken RK, Dawson LA, Grimm J, Yorke E, Jackson A. Local Control After Stereotactic Body Radiation Therapy for Liver Tumors. Int J Radiat Oncol Biol Phys. 2021 May 1;110(1):188-195. doi: 10.1016/j.ijrobp.2017.12.288. Epub 2018 Jan 6.
PubMed 29395629Tse RV, Hawkins M, Lockwood G, Kim JJ, Cummings B, Knox J, Sherman M, Dawson LA. Phase I study of individualized stereotactic body radiotherapy for hepatocellular carcinoma and intrahepatic cholangiocarcinoma. J Clin Oncol. 2008 Feb 1;26(4):657-64. doi: 10.1200/JCO.2007.14.3529. Epub 2008 Jan 2.
PubMed 18172187Miften M, Vinogradskiy Y, Moiseenko V, Grimm J, Yorke E, Jackson A, Tome WA, Ten Haken RK, Ohri N, Mendez Romero A, Goodman KA, Marks LB, Kavanagh B, Dawson LA. Radiation Dose-Volume Effects for Liver SBRT. Int J Radiat Oncol Biol Phys. 2021 May 1;110(1):196-205. doi: 10.1016/j.ijrobp.2017.12.290. Epub 2018 Jan 6.
PubMed 29482870Bujold A, Massey CA, Kim JJ, Brierley J, Cho C, Wong RK, Dinniwell RE, Kassam Z, Ringash J, Cummings B, Sykes J, Sherman M, Knox JJ, Dawson LA. Sequential phase I and II trials of stereotactic body radiotherapy for locally advanced hepatocellular carcinoma. J Clin Oncol. 2013 May 1;31(13):1631-9. doi: 10.1200/JCO.2012.44.1659. Epub 2013 Apr 1.
PubMed 23547075Andolino DL, Johnson CS, Maluccio M, Kwo P, Tector AJ, Zook J, Johnstone PA, Cardenes HR. Stereotactic body radiotherapy for primary hepatocellular carcinoma. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e447-53. doi: 10.1016/j.ijrobp.2011.04.011. Epub 2011 Jun 7.
PubMed 21645977Su TS, Luo R, Liang P, Cheng T, Zhou Y, Huang Y. A prospective cohort study of hepatic toxicity after stereotactic body radiation therapy for hepatocellular carcinoma. Radiother Oncol. 2018 Oct;129(1):136-142. doi: 10.1016/j.radonc.2018.02.031. Epub 2018 Mar 13.
PubMed 29548558Hasan S, Thai N, Uemura T, Kudithipudi V, Renz P, Abel S, Kirichenko AV. Hepatocellular carcinoma with child Pugh-A Cirrhosis treated with stereotactic body radiotherapy. World J Gastrointest Surg. 2017 Dec 27;9(12):256-263. doi: 10.4240/wjgs.v9.i12.256.
PubMed 29359031Nabavizadeh N, Waller JG, Fain R 3rd, Chen Y, Degnin CR, Elliott DA, Mullins BT, Patel IA, Dyer BA, Fakhoury K, Naugler WE, Farsad K, Tanyi JA, Fuss M, Thomas CR Jr, Hung AY. Safety and Efficacy of Accelerated Hypofractionation and Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients With Varying Degrees of Hepatic Impairment. Int J Radiat Oncol Biol Phys. 2018 Mar 1;100(3):577-585. doi: 10.1016/j.ijrobp.2017.11.030. Epub 2017 Nov 27.
PubMed 29413273Cheng JC, Wu JK, Huang CM, Huang DY, Cheng SH, Lin YM, Jian JJ, Yang PS, Chuang VP, Huang AT. Radiation-induced liver disease after radiotherapy for hepatocellular carcinoma: clinical manifestation and dosimetric description. Radiother Oncol. 2002 Apr;63(1):41-5. doi: 10.1016/s0167-8140(02)00061-0.
PubMed 12065102Hollebecque A, Cattan S, Romano O, Sergent G, Mourad A, Louvet A, Dharancy S, Boleslawski E, Truant S, Pruvot FR, Hebbar M, Ernst O, Mathurin P. Safety and efficacy of sorafenib in hepatocellular carcinoma: the impact of the Child-Pugh score. Aliment Pharmacol Ther. 2011 Nov;34(10):1193-201. doi: 10.1111/j.1365-2036.2011.04860.x. Epub 2011 Sep 29.
PubMed 21958438Marrero, J., et al. Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of its Treatment with Sorafenib (GIDEON) second interim analysis in more than 1,500 patients: Clinical findings in patients with liver dysfunction. in ASCO Annual Meeting Proceedings. 2011.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HepQuant: Pilot Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer
- ClinicalTrials.gov ID
- NCT06899152
- Acronym / sponsor ID
- HepQuant / 2025-16581
- Conditions
- Liver Cancer, Hepatocellular Carcinoma, Hepatocellular Cancer, Cholangiocarcinoma, Liver Metastases
- Keywords
- Blood-based biomarkers, Quantitative MR imaging, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- HepQuant, LLC, Perspectum
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- Jul 2031 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 27 Mar 2025 (actual)
- 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 is a pilot and feasibility study assessing the role of quantitative multiparametric MRI and blood-based biomarkers for the measurement of liver function in patients receiving radiation therapy for liver cancer, including hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver metastases regardless of primary histology, that are undergoing photon radiation either in the de-novo or re-irradiation setting. The goal of this study is to prospectively evaluate the feasibility of using quantitative multiparametric MRI to monitor liver function at baseline and following liver radiation therapy.
Detailed description
Historically, the role of fractionated liver radiation therapy (RT) has been limited because of the potential for developing fatal radiation-induced liver disease (RILD), particularly in patients who already have poor liver function due to cirrhosis. Classic RILD generally occurs within 4 months following radiotherapy to the liver and consists of symptoms including fatigue, right upper quadrant pain, ascites, anicteric hepatomegaly, and elevation of liver enzymes especially alkaline phosphatase.
Technical advances in the delivery of RT, particularly using stereotactic body radiotherapy (SBRT) and proton therapy with respiratory gating and image guidance, have facilitated the safe use of radiation dose escalation in unresectable liver cancers. SBRT is a promising and attractive option for HCC patients with cirrhosis. Previous reported experiences have been largely kept to Child-Pugh (CP) A patients with significant liver reserves. The 1 to 2-year local control rate for CP A patients with early-stage tumor have generally been reported around 80-90%. Toxicities rates have also been acceptable with no classic RILD or grade 4 or 5 treatment related toxicities seen 3 months after SBRT. This impressive toxicity result is likely due to keeping with strict dosimetric constraints for the normal liver tissue. Dosimetric parameters reported in literature indicated mean liver disease (MLD) and V20 to be a significant predictor of RILD and elevated liver enzymes in CP A patients with primary HCC.
While there are no overt liver toxicities in CP A patients with primary liver cancer, 10 to 30% of patients will experience a decline in liver function 3 months after SBRT even without disease progression based on the referenced literature. Pre-treatment CP A6 has an increased risk of liver function decline when compared to CP A5. In addition, the tumor volume was also a significant predictor of liver function decline after SBRT.
Patients with CP B or C and primary HCC are more likely to experience liver toxicities as defined by worsening liver function. Dosimetric parameters to predict for fatal RILD for this group has also remained elusive. Yet, it is this particular group of patients that have the worst outcome due to limited treatment options as a result of poor liver reserve to tolerate currently available treatments. The median survival for patients with Child-Pugh B or C HCC treated with best supportive care or sorafenib is approximately 4-5 months according to the literature. Limited institutional experiences have shown that local treatment of these patients with SBRT can potentially improve survival; however, this also comes at a cost of significant potential toxicity. Current reported data are limited, but they do show that patients can experience liver function decline as early as 3 months.
The published experience with SBRT in the treatment of HCC clearly demonstrates a relationship of the underlying degree of hepatic impairment to risk for liver toxicity. However, the data also clearly demonstrate that CP class or score is insufficient to define risk or to monitor treatment effects. The proposed study will use blood-based biomarkers coupled with quantitative imaging (LiverMultiScan™) to fully characterize the effect of SBRT on the liver and the liver cancer.
In vivo Multiparametric MR imaging (mpMRI) is well established at quantifying measures of liver health in patients with liver disease and pre-clinical models of liver disease. In patients with pre-existing/co-existing parenchymal liver disease and liver tumors (primary or secondary), mpMRI can be used to assess the health of the parenchyma and the anatomical and tissue characteristics of the tumor. This allows for decision-making to be based on the health of the liver and the resectability of the tumor. Initial data suggests that this approach can predict which operations will carry higher risk and cost, measured by length of stay in hospital after surgery.
A more sensitive laboratory measure that is currently available in the U.S. as a Laboratory Developed Test (LDT) to measure liver function and will be used in this study as an investigational assay, is the HepQuant DuO test. It measures cholate hepatic uptake from portal circulation and estimates hepatic uptake from systemic circulation to calculate degree of portosystemic shunting as well as hepatic function using the disease severity index (DSI). Both of these measures have been shown to correlate with severity of chronic liver disease and in studies detected and measured the severity and progression of disease and the response to treatments. The HepQuant DuO test is done by oral administration of unconjugated cholate and collection of two serum samples up to 60 minutes after administration. HepQuant DuO may offer a unique capability to assesses liver functional impairment across the spectrum of injury and fibrosis in patients undergoing radiation therapy to better predict clinical outcomes and risk of liver function deterioration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiparametric MRI scans and HepQuant Duo Test | Experimental | Diagnostic Test: HepQuant DuO, Other: Multiparametric MRI Scans |
| Multiparametric MRI scans only | Active comparator | Other: Multiparametric MRI Scans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18
- Patient has the psychological ability and general health needed to provide informed consent, completion of study requirements, and required follow-up
- Patient provides study-specific informed consent prior to study entry
- All primary histologies (Hepatocellular carcinoma or Cholangiocarcinoma) as well as hepatic metastases are eligible
- Prior history of radiation therapy (external beam or radioembolization) is allowed, with no limit to the number of prior courses of radiation therapy
Key exclusion criteria (10 listed)
- Pregnant or breast-feeding females
- Subjects with history of claustrophobia impacting ability to perform MRI during the study
- Subjects who fulfill any of the contraindications for MRI; examples include any ferromagnetic material, any metallic shrapnel or fragments or implanted electronic devices contained within the body or metal-containing tattoos
- Unable to participate in MR assessments due to physical limitations of equipment tolerances (MRI bore size and/or weight limit)
- Any person unable to lie still within the environment of the MRI scanner or maintain a breath hold for the required period to acquire images
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 |
|---|---|---|
| HepQuant DuOHepQuant DuO is a quantitative liver function test. It assesses cholate uptake, a liver specific function. Cholate is a naturally occurring substance that is cleared by the liver. Cholate uptake reflects the health of liver cells. | Diagnostic test | Multiparametric MRI scans and HepQuant Duo Test |
| Multiparametric MRI ScansStandard of care | Other | Multiparametric MRI scans and HepQuant Duo Test, Multiparametric MRI scans only |
Primary outcome
Feasibility of Quantitative MRI
Time frame: Approximately 3 months
Feasibility will be determined by assessing the proportion/percentage of participants who complete at least 2 quantitative multiparametric MRI scans following study enrollment. The proportion/percentage of patients will be summarized by study arm using basic descriptive statistics and a Clopper-Pearson 95% exact confidence interval will be determined.
4 secondary outcomes
Change in Disease Severity Index (DSI) score
Time frame: From baseline to 3 months post-SBRT
Predictive ability of LiverMultiScan
Time frame: 6 months post-SBRT
Change in Total Liver Volume
Time frame: From baseline to 3 months, 6 months, 9 months and 12 months post-SBRT
Change in volume of non-irradiated and irradiated liver lobes
Time frame: From baseline to 3 months, 6 months, 9 months and 12 months post-SBRT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 8365932Russell AH, Clyde C, Wasserman TH, Turner SS, Rotman M. Accelerated hyperfractionated hepatic irradiation in the management of patients with liver metastases: results of the RTOG dose escalating protocol. Int J Radiat Oncol Biol Phys. 1993 Sep 1;27(1):117-23. doi: 10.1016/0360-3016(93)90428-x.
- Background: PubMed 16183481Ben-Josef E, Lawrence TS. Radiotherapy for unresectable hepatic malignancies. Semin Radiat Oncol. 2005 Oct;15(4):273-8. doi: 10.1016/j.semradonc.2005.04.006.
- Background: PubMed 18391616Dawson LA, Guha C. Hepatocellular carcinoma: radiation therapy. Cancer J. 2008 Mar-Apr;14(2):111-6. doi: 10.1097/PPO.0b013e31816a0e80.
- Background: PubMed 18308583Tse RV, Guha C, Dawson LA. Conformal radiotherapy for hepatocellular carcinoma. Crit Rev Oncol Hematol. 2008 Aug;67(2):113-23. doi: 10.1016/j.critrevonc.2008.01.005. Epub 2008 Mar 4.
- Background: PubMed 29395629Ohri N, Tome WA, Mendez Romero A, Miften M, Ten Haken RK, Dawson LA, Grimm J, Yorke E, Jackson A. Local Control After Stereotactic Body Radiation Therapy for Liver Tumors. Int J Radiat Oncol Biol Phys. 2021 May 1;110(1):188-195. doi: 10.1016/j.ijrobp.2017.12.288. Epub 2018 Jan 6.
- Background: PubMed 18172187Tse RV, Hawkins M, Lockwood G, Kim JJ, Cummings B, Knox J, Sherman M, Dawson LA. Phase I study of individualized stereotactic body radiotherapy for hepatocellular carcinoma and intrahepatic cholangiocarcinoma. J Clin Oncol. 2008 Feb 1;26(4):657-64. doi: 10.1200/JCO.2007.14.3529. Epub 2008 Jan 2.
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- 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.
Rikin Gandhi contact
Rafi Kabarriti, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HepQuant DuO and Multiparametric MRI Scans in people with Liver Cancer and Hepatocellular Carcinoma, run by Montefiore Medical Center 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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 11 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rafi Kabarriti, MD (718-405-8550, rkbarri@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Quantitative MRI (time frame: Approximately 3 months). 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 NCT06899152, which also lists 26 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 11 Aug 2026.