18F-DCFPyL PET/CT Scan for Liver Cancer

Overseen By Freddy E Escorcia, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must be taking: Antiretrovirals, HBV suppressive therapy

Disqualifiers: Allergies, Uncontrolled illness, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method to better detect liver cancer, specifically hepatocellular carcinoma (HCC). Researchers aim to determine if a new tracer, piflufolastat F-18 (also known as 18F-DCFPyL), can identify cancer sites more effectively than standard imaging techniques. Participants will undergo PET/CT scans using this tracer to compare its effectiveness against a commonly used tracer. This trial suits adults who might have liver cancer based on previous imaging tests. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in liver cancer detection.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on anti-retroviral therapy for HIV or suppressive therapy for hepatitis B, you must continue these treatments to participate.

What prior data suggests that this radiotracer is safe for PET/CT imaging?

Research has shown that piflufolastat F-18, also known as 18F-DCFPyL, is generally safe for people. This substance is used in imaging tests, especially for prostate cancer. In these studies, most patients did not experience serious side effects. The main concern is the small amount of radiation, similar to that from other common imaging tests.

When side effects occur, they are usually mild. Some people have reported headaches or a warm, flushed feeling, but these are uncommon. The FDA's approval of piflufolastat F-18 for prostate cancer imaging indicates its safety for this purpose.

Overall, piflufolastat F-18 is considered safe for imaging studies, with a low risk of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 18F-DCFPyL PET/CT scan for liver cancer because it offers a more precise way to visualize cancer cells. Unlike standard imaging options like CT or MRI, which often rely on anatomical changes, 18F-DCFPyL targets the prostate-specific membrane antigen (PSMA) that liver cancer cells may express, potentially providing clearer images of cancer spread. This specificity could lead to better treatment decisions and monitoring. By offering higher accuracy in detecting cancerous tissues, it may improve outcomes by tailoring treatments more closely to the actual disease state.

What evidence suggests that this radiotracer is effective for identifying liver cancer?

Research has shown that a special imaging agent, piflufolastat F-18 (18F-DCFPyL), may help identify liver cancer, specifically hepatocellular carcinoma (HCC). In this trial, participants will undergo baseline and post-treatment imaging with 18F-DCFPyL PET/CT scans. Studies have found that these scans can detect cancer more effectively than standard imaging methods. The agent attaches to certain proteins often found in cancer cells, making them easier to see during scans. Early results suggest that this method could improve the accuracy of detecting HCC, potentially leading to better treatment choices. While more research is needed, these initial findings are promising for those considering this imaging option. ^{6 7 8 9 10}

Who Is on the Research Team?

Esther Mena Gonzalez, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

Adults who may have hepatocellular carcinoma (HCC) based on previous imaging, can take oral meds and follow the study plan. They must use contraception if of childbearing potential. Excluded are those with severe claustrophobia, high creatinine levels, unstable health conditions, or weight over 350 lbs.

Inclusion Criteria

I can take pills and will follow the study's treatment plan.

I am a candidate for treatments targeting specific areas of my cancer.

I had hepatitis C but have been treated and cured.

Exclusion Criteria

I have severe claustrophobia that doesn't improve with anxiety medication.

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-DCFPyL or other agents used in study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Imaging

Participants undergo a baseline 18F-DCFPyL PET/CT scan and a standard of care CT and/or MRI

2 months

2 visits (in-person)

Treatment and Biopsy

Participants receive standard treatment for HCC and undergo a tumor biopsy

Varies based on treatment

1 visit (in-person)

Post-treatment Imaging

Participants with positive baseline imaging undergo post-treatment 18F-DCFPyL PET/CT imaging

16 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Every 3 months for 2 years, then yearly for 3 years

What Are the Treatments Tested in This Trial?

Interventions

• CT
• F18-DCFPyL
• F18-FDG
• MRI

Trial Overview The trial is testing a new radiotracer called 18F-DCFPyL for identifying HCC compared to the standard tracer 18F-FDG. Participants will undergo PET/CT scans using these tracers and continue with their usual cancer treatments.

How Is the Trial Designed?

Group I: Arm 1, Cohort 1 Baseline and Post-treatment Imaging with Piflufolastat F-18 (18F-DCFPyL) Experimental Treatment 5 Interventions

Piflufolastat F-18 (18F-DCFPyL) positron emission tomography computed tomography (PET/CT) imaging, CT and/or magnetic resonance imaging (MRI) and standard of care local ablative treatment

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Combining F-18 FDG and C-choline PET/CT significantly improves the diagnostic sensitivity for hepatocellular carcinoma (HCC), increasing detection rates from 63.1% to 89.5% in a study of 76 patients.

While F-18 FDG scans were positive in 61.1% of patients, the C-choline scan was able to detect HCC in 71.4% of those with initially negative F-18 FDG results, highlighting its effectiveness in identifying well-differentiated tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

F-18 FDG in conjunction with 11C-choline PET/CT in the diagnosis of hepatocellular carcinoma. Wu, HB., Wang, QS., Li, BY., et al.[2016]

MRI using mangafodipir trisodium (MnDPDP) detected 98 liver lesions, including two more than computed tomography (CT), demonstrating its superior sensitivity for identifying liver metastases in patients undergoing chemotherapy for colorectal cancer.

Both imaging techniques provided good quality results, but the enhanced MRI with MnDPDP showed a significant advantage over unenhanced MRI and CT, making it a valuable tool for monitoring liver lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Detection of liver metastases in colorectal cancer on chemotherapy. Comparative study between MRI with teslascan and computed tomography with intravenous contrast media]. Beziat, C., Pilleul, F., Yzebe, D., et al.[2019]

In a study of 20 patients suspected of having pancreatic cancer, spiral CT detected 8 malignant lesions while MRI detected 7, indicating that both imaging techniques are effective but have slight differences in detection rates.

MRI enhanced with mangafodipir trisodium (Mn-DPDP) improved the clarity of pancreatic lesions, suggesting it may enhance diagnostic confidence and potentially improve detection and staging accuracy, although further research with a larger patient group is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI with mangafodipir trisodium in the detection of pancreatic tumours: comparison with helical CT. Rieber, A., Tomczak, R., Nüssle, K., et al.[2016]

The pilot study demonstrated that [18F]FSPG PET/CT has a 75% detection rate for hepatocellular carcinoma (HCC), outperforming standard imaging techniques in identifying tumors, especially those lacking typical MRI enhancement patterns.

In a comparison with [11C]acetate PET/CT, [18F]FSPG PET/CT showed significantly higher tumor-to-liver background ratios, suggesting it may provide better imaging quality and insights into HCC tumor metabolism, warranting further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of [18F]FSPG PET to Image Hepatocellular Carcinoma: First Clinical Evaluation in a US Population. Kavanaugh, G., Williams, J., Morris, AS., et al.[2019]

In a study involving 30 patients with colorectal cancer liver metastases, Primovist-enhanced MRI (P-MRI) demonstrated superior sensitivity (96%) and positive predictive value (PPV of 0.91) compared to MDCT and PET/CT, making it a more effective imaging modality for detecting liver lesions.

P-MRI was able to identify more lesions than both MDCT and PET/CT, suggesting it provides significant added value in the pre-surgical assessment of patients eligible for liver resection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of MDCT, PET/CT and gadoxetic acid (Primovist(®))-enhanced MRI in patients with colorectal liver metastases being considered for hepatic resection: initial experience in a single centre. Chan, VO., Das, JP., Gerstenmaier, JF., et al.[2021]

In a study of 404 patients, contrast-enhanced MRI using mangafodipir trisodium (MnDPDP) significantly improved the detection and characterization of hepatic masses compared to unenhanced MRI and enhanced CT, leading to better diagnostic accuracy.

The use of MnDPDP-enhanced MRI provided additional diagnostic information in 48% of patients, resulting in changes to patient management in 6% of cases, highlighting its potential impact on clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults: results of the U.S. Multicenter phase III clinical trials. Efficacy of early imaging. Federle, M., Chezmar, J., Rubin, DL., et al.[2019]

In a study involving 39 patients with known or suspected hepatocellular carcinoma (HCC), the hepatocyte-specific PET tracer FDGal demonstrated a 100% specificity in identifying HCC, correctly detecting the disease in 22 out of 23 patients before treatment.

FDGal PET/CT not only confirmed HCC in patients where conventional imaging was inconclusive but also identified extrahepatic disease in nine patients, highlighting its potential as a valuable diagnostic tool for both intra- and extrahepatic HCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential use of 2-[¹⁸F]fluoro-2-deoxy-D-galactose as a PET/CT tracer for detection of hepatocellular carcinoma. Sørensen, M., Frisch, K., Bender, D., et al.[2021]

In a study involving 145 patients, Mn-DPDP-enhanced magnetic resonance imaging (MRI) correctly classified focal liver lesions in 74% of cases, significantly outperforming dual-phase spiral computed tomography (CT), which only achieved 57% accuracy (P = 0.001).

Enhanced MRI also excelled in distinguishing between malignant and benign lesions (85% accuracy) and identifying hepatocellular versus nonhepatocellular lesions (90% accuracy), compared to 68% and 64% for dual-phase CT, respectively, indicating its superior diagnostic capability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of liver lesions with mangafodipir trisodium-enhanced MR imaging: multicenter study comparing MR and dual-phase spiral CT. Oudkerk, M., Torres, CG., Song, B., et al.[2015]

In a study involving 46 patients with 96 hepatocellular carcinomas, gadopentetate dimeglumine-enhanced MRI demonstrated superior diagnostic accuracy and sensitivity compared to Mn-DPDP-enhanced MRI, with a sensitivity of 87.5% versus 72.4%.

The false-negative rate for Mn-DPDP was significantly higher (27.6%) than for gadopentetate dimeglumine (12.5%), particularly for small lesions under 2 cm, indicating that gadopentetate dimeglumine is more effective for detecting smaller tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI for detection of hepatocellular carcinoma: comparison of mangafodipir trisodium and gadopentetate dimeglumine contrast agents. Youk, JH., Lee, JM., Kim, CS.[2015]

Citations

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A Pilot Study to Assess the Clinical Utility of PYLARIFY PET ... Primary Objective: To assess the diagnosis accuracy of PYLARIFY (piflufolastat F18 ) PET-CT for imaging patients with suspected metastatic ...

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18F-DCFPyL PET/CT in Hepatocellular Carcinoma Point estimates and 95% confidence intervals of the positive predictive values of piflufolastat F-18 (18F-DCFPyL) positron emission tomography scan and computed ...

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18F-DCFPyL PET/CT in Hepatocellular Carcinoma - NCI Objective: To learn if a radiotracer called piflufolastat F-18 (18F-DCFPyL), can identify sites of HCC better than current standard imaging. Eligibility: Adults ...

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FDA Accepts NDA for New Formulation of PSMA PET ... The new formulation of piflufolastat F 18 is expected to optimize the manufacturing process and increase batch size by approximately 50%, ...

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18F-DCFPyL PET/CT for Initially Diagnosed and ... In sample 1, 25 of the 92 men (27%) demonstrated DCFPyL-avid lesions suspicious for distant metastases. Biopsy was performed in 23 of the 25 men ...

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PYLARIFY® (piflufolastat F 18) injection, for intravenous use The safety and efficacy of PYLARIFY were evaluated in two prospective, open-label, multi-center clinical studies in men with prostate cancer: OSPREY ( ...

7. pylarify.com pylarify.com/efficacy-safety/safety

Explore PYLARIFY® Safety Data & Side Effects PYLARIFY is a PSMA-targeted PET imaging agent for prostate cancer. Learn more about PYLARIFY safety data and adverse reactions.

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Piflufolastat F-18 | C18H23FN4O8 | CID 52950901 - PubChem Piflufolastat F18, also called [F-18]-DCFPyL, is a urea-based radiopharmaceutical that binds to PSMA and allows for the visualization of cancerous prostate ...

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PYLARIFY PET-CT for Detection of Metastasis in ... The goal of this clinical research study is to learn if piflufolastat F18 can be used in imaging scans for patients with breast, liver, or pancreatic cancer.

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Pylarify (piflufolastat F 18) dosing, indications, interactions, ... Radiation exposure is associated with a dose-dependent increased risk of cancer; Ensure safe drug handling and patient preparation procedures to protect ...