Assessing blood biomarkers and MRI for liver cancer patients undergoing radiation therapy
HepQuant: Pilot Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer
This study is testing if using special MRI scans and blood tests can help doctors keep track of liver health in patients with liver cancer who are getting radiation therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT06899152 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the feasibility of using quantitative multiparametric MRI and blood-based biomarkers to monitor liver function in patients receiving radiation therapy for liver cancer, including hepatocellular carcinoma and cholangiocarcinoma. Participants will undergo photon radiation therapy, either as a new treatment or re-irradiation, while their liver function is assessed at baseline and after treatment. The study aims to improve understanding of liver function changes and the safety of radiation therapy in patients with varying liver conditions.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with liver cancer, including hepatocellular carcinoma or cholangiocarcinoma, who are receiving radiation therapy.
Not a fit: Patients with severe liver dysfunction or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance monitoring and treatment strategies for liver cancer patients, potentially reducing the risk of radiation-induced liver disease.
How similar studies have performed: Previous studies have shown promise in using advanced radiation techniques for liver cancer, but this specific approach combining MRI and blood biomarkers is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
The Bronx, New York
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Rafi Kabarriti, MD — Montefiore Medical Center
- Study coordinator: Rafi Kabarriti, MD
- Email: rkbarri@montefiore.org
- Phone: 718-405-8550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.