Clinical trial · Interventional
A Pilot Study For Patients Receiving Radiation Therapy for Liver Cancer
Pilot Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI indicated that the site was unable to procure shunt. No participants were enrolled and this HepQuant study will be withdrawn.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the role of quantitative MR imaging and blood-based biomarkers to measure liver function in patients receiving radiation therapy for liver cancer or cancer that has spread to the liver.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Hepatocellular | Hepatocellular Carcinoma | CURATED_BROADER | 0.80 |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multiparametric MRI scans | Device | — | UNRESOLVED |
| Multiparametric MRI scans + HepQuantShunt Test | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Multiparametric MRI scan group
- description
- Multiparametric MRI scans will be used to evaluate baseline degree of liver fibroinflammation and function as well as temporal changes in liver fibroinflammation and function using MRI-based LiverMultiScan software.
- interventionNames
- Device: Multiparametric MRI scans
- type
- EXPERIMENTAL
- label
- Multiparametric MRI scans + HepQuantShunt Test group
- description
- Eligible patients can have previously undergone any modality and number of prior treatments for their hepatic malignancies, must be considered for either liver photon or proton radiation in the de-novo or re-irradiation setting and can be simultaneously enrolled on parallel trials.
- interventionNames
- Device: Multiparametric MRI scans
- Device: Multiparametric MRI scans + HepQuantShunt Test
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 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 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 * 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 kit including 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, colesalvalem) that might act within the gut lumen to bind the orally administered d4-cholate in the HepQuant test
References
Publications (24)
- BACKGROUNDRussell 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. PMID 8365932
- BACKGROUNDBen-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. PMID 16183481
- BACKGROUNDDawson LA, Guha C. Hepatocellular carcinoma: radiation therapy. Cancer J. 2008 Mar-Apr;14(2):111-6. doi: 10.1097/PPO.0b013e31816a0e80. PMID 18391616
- BACKGROUNDOhri 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. PMID 29395629
- BACKGROUNDTse 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. PMID 18172187
- BACKGROUNDMiften 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. PMID 29482870
- BACKGROUNDBujold 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.