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New treatment option for Liver Cancer
Official title HepQuant: 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
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The following criteria must be met for people to be considered for the trial. Additional
You likely can't join if
- must be met for people interested in the HepQuant subset of the trial. The first 20 qualifying people will be enrolled for the additional HepQuant...
- 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
See the full eligibility criteria
- The following criteria must be met for people to be considered for the trial. Additional
- must be met for people interested in the HepQuant subset of the trial. The first 20 qualifying people 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
- people with history of claustrophobia impacting ability to perform MRI during the study
- people 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...
- 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
- people with extensive resection of large segments of small intestine (short gut) or severe gastroparesis (e.g., diabetic or medication-induced gastroparesis)
- people 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...
- people 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)
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.