A new test could reveal how radiation affects the liver
NCT ID NCT06899152
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This pilot study explores whether a combination of advanced MRI scans and a blood test called HepQuant DuO can measure liver function in people receiving radiation therapy for liver cancer. The study will enroll about 40 adults with liver cancer or liver metastases. The goal is to see if these tests are feasible and can detect changes in liver health before and after radiation, which could help guide future treatment decisions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HepQuant DuO diagnostic test and multiparametric MRI scans
- What this could lead to
- If successful, this could lead to a non-invasive way to monitor liver health during radiation therapy, potentially helping doctors tailor treatment to protect liver function.
- What could go wrong
- This is a small pilot study focused on feasibility, not effectiveness. The tests may not reliably reflect liver function or may not be practical in routine care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
The following criteria must be met for subjects to be considered for the trial. Additional exclusion criteria must be met for subjects interested in the HepQuant subset of the trial. The first 20 qualifying subjects will be enrolled for the additional HepQuant test. Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 Exclusion criteria for HepQuant SHUNT DuO testing ONLY: * Known history or suspected hypersensitivity to human serum albumin, or its preparations * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Montefiore Medical Center
RECRUITINGThe Bronx, New York, 10467, United States
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