Trial Summary
What is the purpose of this trial?This prospective clinical trial will evaluate PET/CT and genomic liquid biopsy based biomarkers as predictors of clinical therapeutic response to immune-checkpoint inhibitor (ICI) therapy for patients with inoperable hepatocellular carcinoma (HCC). The primary objective of this diagnostic trial is to assess the accuracy of pre-treatment fluorine-18 (18F-) fluorocholine (FCH) PET/CT for predicting a lack of objective response (LOR) after 16 weeks of ICI therapy.
Is the treatment in the trial 'Fluorine-18 Fluorocholine PET/CT for Liver Cancer' a promising treatment?Yes, the treatment using Fluorine-18 Fluorocholine PET/CT is promising for liver cancer. It helps in detecting liver cancer more effectively than some other methods, especially for a type of liver cancer called hepatocellular carcinoma. This imaging technique can predict how well a patient might respond to treatment and help in managing the disease better.25789
What safety data exists for Fluorine-18 Fluorocholine in liver cancer treatment?Preclinical studies on [(18)F]Fluorocholine have been conducted to assess acute toxicity, biodistribution, pharmacokinetics, and radiation dosimetry, which are essential for supporting its use in clinical trials. These studies provide foundational safety data necessary for regulatory approval, particularly in Brazil. Additionally, the pharmacokinetics and radiation dosimetry of 18F-Fluorocholine have been evaluated using murine and human biodistribution data, further contributing to the understanding of its safety profile.12689
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on a non-targeted therapeutic agent while participating in the trial.
What data supports the idea that Fluorine-18 Fluorocholine PET/CT for Liver Cancer is an effective treatment?The available research shows that Fluorine-18 Fluorocholine PET/CT is effective in managing liver cancer, specifically hepatocellular carcinoma (HCC). One study found that using this treatment before and after other therapies can help predict how well a patient will respond to treatment and their overall outlook. Another study compared Fluorine-18 Fluorocholine with another imaging method and found it to be better at detecting liver cancer in patients with liver disease. This suggests that Fluorine-18 Fluorocholine PET/CT is a useful tool in diagnosing and managing liver cancer.23489
Eligibility Criteria
This trial is for adults with inoperable liver cancer (Hepatocellular Carcinoma) who are under a medical oncologist's care, have certain levels of liver function and no serious conditions that would affect their ability to undergo imaging. Pregnant or lactating women and those on non-targeted cancer therapies cannot participate.Inclusion Criteria
My liver cancer is at an intermediate or advanced stage.
I am 18 years old or older.
My liver function is relatively good.
My liver cancer diagnosis follows the latest expert guidelines.
My kidneys work well enough to clear at least 40 mL/min of creatinine.
Exclusion Criteria
I have a health condition that makes it hard for me to undergo imaging tests.
My weight is under 500 lbs.
Treatment Details
The study tests if PET/CT scans using fluorine-18 fluorocholine can predict the effectiveness of immune-checkpoint inhibitor therapy in patients after 16 weeks. It also looks at genomic markers from liquid biopsies as potential predictors.
1Treatment groups
Experimental Treatment
Group I: Tested with BiomarkersExperimental Treatment1 Intervention
For this single arm study, all enrolled subjects will undergo diagnostic testing with FCH PET/CT and genomic liquid biopsy before treatment involving an immune checkpoint inhibitor agent. A fluorine-18 fluorodeoxyglucose (FDG) PET/CT may also be performed before treatment and after 8 weeks if the pre-treatment FCH PET/CT shows low or heterogeneous tumor uptake.
Find a clinic near you
Research locations nearbySelect from list below to view details:
The Queen's Medical CenterHonolulu, HI
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Who is running the clinical trial?
Queen's Medical CentreLead Sponsor
Queen's Medical CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Pharmacokinetics and radiation dosimetry of 18F-fluorocholine. [2022]18F-Fluorocholine (fluoromethyl-dimethyl-2-hydroxyethylammonium [FCH]) has been developed as an oncologic probe for PET. This study evaluates the kinetics and radiation dosimetry of 18F-FCH using murine and human biodistribution data.
Fluoromethylcholine PET in recurrent multifocal hepatoma. [2016]F-18 fluorodeoxyglucose (FDG) positron emission tomography (PET) has variable efficacy in evaluating hepatocellular carcinoma. We present a case of a new oncologic imaging tracer fluoromethylcholine (FCH), which has visualized recurrent multifocal hepatoma in a patient with a poor FDG avid hepatic tumour. The lesions demonstrated on FCH PET correlated well with the findings on CT hepatic angiography.
Detection of hepatocellular carcinoma with PET/CT: a prospective comparison of 18F-fluorocholine and 18F-FDG in patients with cirrhosis or chronic liver disease. [2022]This prospective study aimed to compare the diagnostic performance of (18)F-fluorocholine and (18)F-FDG for detecting and staging hepatocellular carcinoma (HCC) in patients with chronic liver disease and suspected liver nodules.
Prognostic value of metabolic parameters and clinical impact of ¹⁸F-fluorocholine PET/CT in biochemical recurrent prostate cancer. [2022]To evaluate the therapeutic impact of (18)F-fluorocholine (FCH) PET/CT in biochemical recurrent prostate cancer (PC) and to investigate the value of quantitative FCH PET/CT parameters in predicting progression-free survival (PFS).
Metabolic characteristics distinguishing intrahepatic cholangiocarcinoma: a negative pilot study of (18)F-fluorocholine PET/CT clarified by transcriptomic analysis. [2022]PET using fluorine-18 fluorocholine ((18)F-fluorocholine) may detect malignancies that involve altered choline metabolism. While (18)F-fluorocholine PET/CT has shown greater sensitivity for detecting hepatocellular carcinoma (HCC) than (18)F-fluoro-D-deoxyglucose (FDG) PET/CT, it is not known whether it can also detect intrahepatic cholangiocarcinoma (ICC), a less common form of primary liver cancer. Clinical, radiographic, and histopathologic data from 5 patients with ICC and 23 patients with HCC from a diagnostic trial of liver (18)F-fluorocholine PET/CT imaging were analyzed to preliminarily evaluate (18)F-fluorocholine PET/CT for ICC. Imaging was correlated with whole-genome expression profiling to identify molecular pathways associated with tumor phenotypes. On PET/CT, all ICC tumors demonstrated low (18)F-fluorocholine uptake with a significantly lower tumor to mean background uptake ratio than HCC tumors (0.69 vs. 1.64, p
Preclinical acute toxicity, biodistribution, pharmacokinetics, radiation dosimetry and microPET imaging studies of [(18)F]fluorocholine in mice. [2018][(18)F]Fluorocholine ([(18)F]FCH) has been proven to be effective in prostate cancer. Since [(18)F]FCH is classified as a new radiopharmaceutical in Brazil, preclinical safety and efficacy data are required to support clinical trials and to obtain its approval. The aim of this work was to perform acute toxicity, biodistribution, pharmacokinetics, radiation dosimetry and microPET imaging studies of [(18)F]FCH. The results could support its use in nuclear medicine as an important piece of work for regulatory in Brazil.
[18F]Fluorocholine PET/CT Imaging of Liver Cancer: Radiopathologic Correlation with Tissue Phospholipid Profiling. [2019]Label="PURPOSE">[18F]fluorocholine PET/CT can detect hepatocellular carcinoma (HCC) based on imaging the initial steps of phosphatidylcholine synthesis. To relate the diagnostic performance of [18F]fluorocholine positron emission tomography (PET)/x-ray computed tomography (CT) to the phospholipid composition of liver tumors, radiopathologic correspondence was performed in patients with early-stage liver cancer who had undergone [18F]fluorocholine PET/CT before tumor resection.
Comparison of [18F]Fluorocholine and [18F]Fluordesoxyglucose for assessment of progression, lung metastasis detection and therapy response in murine 4T1 breast tumor model. [2023]The [18F]Fluorocholine ([18F]FCH) tracer for PET imaging has been proven to be effective for several malignances. However, there are only a few studies related to its breast tumor applicability and they are still limited. The aim of this study was investigate the efficacy of [18F]FCH/PET compared to [18F]FDG/PET in a murine 4T1 mammary carcinoma model treated and nontreated. [18F]FCH/PET showed its applicability for primary tumor and lung metastasis detection and their use for response monitoring of breast cancer therapeutics at earlier stages.
Baseline and Post-treatment 18F-Fluorocholine PET/CT Predicts Outcomes in Hepatocellular Carcinoma Following Locoregional Therapy. [2020]Label="BACKGROUND AND AIMS"> 18F-fluorocholine positron emission tomography/computed tomography (18F-FCH PET/CT) is an emerging functional imaging technique in the diagnosis and management of hepatocellular carcinoma (HCC). The aim of this study was to assess the ability of a pre- and post-treatment 18F-FCH PET/CT to predict prognosis and treatment response in early-stage HCC.