Fluorine-18 Fluorocholine PET/CT for Liver Cancer

(ExTRACT-HCC Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Sandi A Kwee, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Queen's Medical Centre

Must be taking: Immune checkpoint inhibitors

Must not be taking: Non-targeted therapeutics

Disqualifiers: Pregnancy, Serious medical condition, others

No Placebo Group

Prior Safety Data

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.

Will I have to stop taking my current medications?

The trial 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 effectiveness of the treatment Fluorine-18 fluorocholine for liver cancer?

Research shows that Fluorine-18 fluorocholine PET/CT is useful in predicting outcomes and treatment responses in liver cancer, specifically hepatocellular carcinoma. It has been effective in detecting liver tumors and monitoring treatment responses, which suggests its potential usefulness in managing liver cancer. ^{1 2 3 4 5}

Is 18F-Fluorocholine PET/CT safe for use in humans?

Preclinical studies in mice have been conducted to assess the safety of 18F-Fluorocholine, including its toxicity and how it spreads in the body. These studies are important steps before human trials, suggesting that it has been considered safe enough to proceed to further testing in humans. ^{1 2 3 6 7}

How does 18F-Fluorocholine PET/CT differ from other treatments for liver cancer?

18F-Fluorocholine PET/CT is unique because it uses a special imaging tracer to detect liver cancer by targeting altered choline metabolism, which is more effective than traditional FDG PET/CT for certain liver tumors. This imaging technique helps in diagnosing and predicting treatment outcomes for hepatocellular carcinoma, offering a more sensitive approach to detecting and monitoring liver cancer. ^{1 2 3 8 9}

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

ALT and AST ≤5x upper limit of normal

I have at least one tumor that can be measured on a scan.

My doctor thinks I should get immune therapy due to past treatment failure and my current health status.

Exclusion Criteria

I have a health condition that makes it hard for me to undergo imaging tests.

I am currently not on any non-targeted cancer treatments but can be in an ICI trial.

I am not pregnant or breastfeeding.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Testing

Participants undergo FCH PET/CT and genomic liquid biopsy before ICI treatment. FDG PET/CT may be performed if needed.

1-2 weeks

Treatment

Participants receive immune-checkpoint inhibitor (ICI) therapy for 16 weeks.

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment using RECIST v1.1 criteria.

4 weeks

Treatment Details

Interventions

• Fluorine-18 fluorocholine (Imaging Agent)

Trial Overview 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.

Participant Groups

Group I: Tested with Biomarkers Experimental Treatment 1 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 Nearby Select from list below to view details:

The Queen's Medical Center Honolulu, HI

Who Is Running the Clinical Trial?

Queen's Medical Centre Lead Sponsor

Queen's Medical Center Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

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.

2. Australia pubmed.ncbi.nlm.nih.gov

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.

3. England pubmed.ncbi.nlm.nih.gov

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.

4. United States pubmed.ncbi.nlm.nih.gov

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.

5. Germany pubmed.ncbi.nlm.nih.gov

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).

6. England pubmed.ncbi.nlm.nih.gov

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.

7. United States pubmed.ncbi.nlm.nih.gov

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.

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

[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.