Hepatocellular CarcinomaPhase 2NCT05009979
18F-DCFPyL PET/CT in Hepatocellular Carcinoma
A Phase 2 study testing F18-FDG, MRI and CT in people with Hepatocellular Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: A radiotracer (or tracer) is a radioactive substance. It is used in Positron Emission Tomography (PET) imaging to help see specific sites in the body. Researchers want to learn if a new tracer can help them better identify hepatocellular cancer (HCC) in people. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- F18-FDG, MRI and CT
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2023to 20 Nov 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High radiological suspicion of hepatocellular carcinoma (LR4 (probably hepatocellular carcinoma) or LR5 (definitely hepatocellular carcinoma) based on the most current version of Liver Imaging Reporting \& Data System (LI-RADS) with at least one measurable lesion on standard imaging modality computed tomography (CT) and/or magnetic resonance imaging (MRI).
- Eligible for local therapies (included but not limited to surgical resection, stereotactic radiation therapy, transarterial chem/radio/bland embolization, microwave ablation, radiofrequency ablation).
- Ability to take oral medication and be willing to adhere to the study intervention regimen.
- Age >=18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status <=2.
- Known human immunodeficiency virus (HIV)-infected individuals must be on effective anti-retroviral therapy with undetectable viral load within 6 months.
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- Known chronic hepatitis B virus (HBV) infected individuals, must be on suppressive therapy with undetectable viral load.
- Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured.
- The effects of piflufolastat F-18 (18F-DCFPyL) (study drug) on the developing human fetus are unknown. For this reason and because this agent as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 2 months after each study positron emission tomography and computed tomography (PET/CT) imaging. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Ability of subject to understand and the willingness to sign a written informed consent document
Who cannot join
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-DCFPyL, or other agents used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects with severe claustrophobia unresponsive to oral anxiolytics.
- Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures.
- Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
- Serum creatinine > 2 times the upper limit of normal
- Pregnant women are excluded from this study because 18F-DCFPyL is an agent with the potential for teratogenic or abortifacient effects. as well as other agents used in this trial are known to be teratogenic.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
A radiotracer (or tracer) is a radioactive substance. It is used in Positron Emission Tomography (PET) imaging to help see specific sites in the body. Researchers want to learn if a new tracer can help them better identify hepatocellular cancer (HCC) in people.
Read more
Objective:
To learn if a radiotracer called piflufolastat F-18 (18F-DCFPyL), can identify sites of HCC better than current standard imaging.
Eligibility:
Adults aged 18 years and older who may have HCC based on previous standard imaging.
Design:
Participants will be screened with a medical history, physical exam, and blood tests. They will have a computed tomography (CT) and/or magnetic resonance imaging (MRI) scan.
Participants will have a whole-body positron emission tomography (PET/CT) scan. The PET and CT scanners use x-rays to make pictures of the inside of the body. The PET uses a tracer to help make the pictures. Participants will get an intravenous (IV) injection of 18F-DCFPyL 1 hour before the scan.
Within two weeks, participants will have a Fludeoxyglucose F 18 (18F-FDG) PET/CT scan. 18F-FDG is a commonly used tracer. They will get 18F-FDG via IV 1 hour before the scan.
Participants will have a CT/magnetic resonance imaging (MRI) within 2 months of the first 18F-DCFPyL PET/CT.
Participants will have standard treatment for their cancer. During treatment, they will have a tumor biopsy. If the biopsy shows they do not have HCC, they will be removed from the study.
For participants who have HCC and their cancer was identified in the 18F-DCFPyL PET/CT, they will have a second 18F-DCFPyL PET/CT and 18F-FDG PET/CT.
Participants will have follow-up visits every 3 months for 2 years. Then they will have yearly visits for 3 years.
Read the detailed description
Background:
Prostate specific membrane antigen is overexpressed in high-grade tumors, and increases when de-differentiation, metastatic or hormone-refractory disease occur, making the expression level a prognostic factor for disease outcome.
It has been shown that prostate-specific membrane antigen (PSMA) can be expressed not only on prostate cancer cells, but also on cell lines of other malignancies, as well as tumor endothelium.
A recent publication reported that nearly 95% of hepatocellular carcinoma (HCC) stained positive for PSMA in the tumor vasculature. Research suggests that the process of endothelial cell recruitment to HCC occurs early and throughout the process of hepatic tumorigenesis, making an endothelial cell tracer an ideal marker to detect early disease.
18F-DCFPyL, a second generation PSMA PET agent, binds with high affinity to PSMA yet clears rapidly from the blood pool and thus, whole-body PET imaging with this agent, may provide a new tool in staging high risk cancers and detecting recurrent disease.
We propose to expand our clinical work using 18F-DCFPyL and evaluate its usefulness for detecting sites of hepatocellular carcinoma.
Objective:
To assess the ability of 18F-DCFPyL PET/CT imaging to detect sites of hepatocellular carcinoma
Eligibility:
Participants >= 18 years old
High radiological suspicion of hepatocellular carcinoma (HCC) with at least one measurable lesion on standard imaging modality (CT and/or MRI)
Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2
Design:
This is a multi-site imaging study enrolling participants with suspected hepatocellular carcinoma. The accrual ceiling is set to 50 participants.
All participants will undergo a baseline 18F-DCFPyL PET/CT scan. A standard of care CT and/or MRI will be performed within 2 months of the 18F-DCFPyL PET/CT. Participants will be also scanned with an 18F-FDG PET/CT imaging within approximately 2 weeks of the 18F-DCFPyL PET/CT imaging.
Participants will be scheduled to undergo a biopsy prior to or during standard of care local treatment for HCC (e.g., resection, radiofrequency ablation, microwave ablation, transarterial embolization (TAE), stereotactic body radiotherapy (SBRT)).
Participants with a baseline positive 18F-DCFPyL-PET/CT imaging (i.e. with the presence of DCFPyL-avid tumor/s) and biopsy confirming HCC diagnosis will undergo a post-treatment 18F-DCFPyL PET/CT imaging during the first routine follow-up period, typically within 16 weeks. Subjects with negative tumor uptake at baseline 18F-DCFPyL-PET/CT will not be re-scanned post-treatment but will remain in follow-up.
Participants with a positive HCC biopsy will be followed for 5 years to assess progression free survival.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- F18-FDG, MRI, CT, F18-DCFPyL, Tumor biopsy
- Keywords
- Imaging, Liver Cancer, Radiotracer, PSMA
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F18-FDGDrug
Also called Fludeoxyglucose F 18
Within approximately 2 weeks of each piflufolastat F-18 (18F-DCFPyL) positron emission tomography/ computed tomography (PET/CT) scan, participants will be scanned with a fludeoxyglucose F 18 (18F-FDG) PET/CT imaging at the NIH Clinical Center using standard procedures. The 18F-FDG PET/CT imaging performed will allow the localization of viable tumor sites and characterize their FDG metabolism for comparison with 18F-DCFPyL imaging. The 18F-FDG PET/CT imaging will consist of an 18F-FDG injection and PET/CT imaging performed approximately 1 hour post 18F-FDG injection. A corresponding low dose CT scan for attenuation correction and co-registration purposes will be performed prior to the PET image.
MRIDevice
Also called Magnetic resonance imaging
A standard of care computed tomography (CT) and/or magnetic resonance imaging (MRI) will be performed within 2 months of each piflufolastat F-18 (18F-DCFPyL) positron emission tomography (PET/CT).
CTDevice
Also called Computed tomography
A standard of care computed tomography (CT) and/or magnetic resonance imaging (MRI) will be performed within 2 months of each piflufolastat F-18 (18F-DCFPyL) positron emission tomography (PET/CT).
F18-DCFPyLDrug
Also called piflufolastat F-18
Each subject will receive a single intravenous (IV) dose of piflufolastat F-18 (18F-DCFPyL) by bolus injection at a rate of approximately 1 ml/3-5 sec. The maximum amount of injected active drug will be less than 4.02 microgram. The target administered activity will be 9 mCi. The 18F-DCFPyL positron emission tomography and computed tomography (PET/CT) imaging will consist of the 18F-DCFPyL injection, followed by approximately 45 min dynamic CT imaging of a single bed position (including the liver lesion), and a static whole-body PET/CT imaging (top of head to mid-thighs) performed at 1 hour (+/-10 minutes) post 18F-DCFPyL injection. Only a single injection of 18F-DCFPyL is required. The initial 45 minutes dynamic regional scan will be used to determine the kinetics of 18F-DCFPyL within the tumor as compared with normal liver and other background.
Tumor biopsyProcedure or surgery
Principal investigator discretion pre-treatment or during surgical resection.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1, Cohort 1 Baseline and Post-treatment Imaging with Piflufolastat F-18 (18F-DCFPyL) | Experimental | 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 Receives: Drug: F18-FDG; Device: MRI; Device: CT; Drug: F18-DCFPyL; Procedure: Tumor biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Predictive Value (PPV) Defined as the Proportion of Histopathology Positive Lesions as Measured by the Maximum Standardized Uptake (SUVmax) Value
Positive predictive value is defined as the proportion of histopathologically positive lesions. Positron emission tomography (PET) positivity was measured by the maximum standardized uptake (SUVmax) value. The 95% confidence intervals of the positive predictive value of piflufolastat F-18 (18F-DCFPyL) positron emission tomography scan and computed tomography (PET/CT) will be reported in which the confidence limits are the 2.5th and 97.5th percentile of the 2000 bootstrap samples obtained by random sample without replacement at the participant level to account for inter-lesion correlation. For lesions within the liver, a focal abnormal area of increased 18F-DCFPyL activity higher than the surrounding liver uptake (SUVmax more than x 1.2 times than the normal liver-SUV mean) will be considered positive. For lesions outside the liver, a positive lesion is defined as focal abnormal uptake higher than the blood pool or surrounding normal organ or soft tissue background.
Measured: Baseline, post ablation, and disease progression, an average of 3.87 months
Point Estimates of the Positive Predictive Value of Piflufolastat F-18 (18F-DCFPyL)
Positive predictive value of the DCFPyL PET imaging agent is defined as the proportion of radiologically positive lesions (true positives) that were PET positive, over the radiologically (CT/MRI) positive lesions that were PET positive (true positives) added to the radiologically negative lesions that were PET positive (false positives). Point estimates and 95% confidence intervals of the positive predictive values of piflufolastat F-18 (18F-DCFPyL) positron emission tomography scan and computed tomography (PET/CT) will be reported in which the confidence limits are the 2.5th and 97.5th percentile of the 2000 bootstrap samples obtained by random sample without replacement at the participant level to account for inter-lesion correlation.
Measured: Baseline, post ablation, disease progression, an average of 3.87 months
Secondary outcomes (4)
Lesion Level Sensitivity
Lesion level sensitivity is defined as true positive (TP)/[TP+ false negative (FN], being TP = true positive lesions (i.e., positron emission tomography (PET) positive lesions that are histologically positive) and FN = false negative lesions (i.e., PET negative lesions that are histologically positive) . The lesion level sensitivity of piflufolastat F-18 (18F-DCFPyL) positron emission tomography scan and a computed tomography (PET/CT) and CT/magnetic resonance imaging (MRI) will be calculated and compared. The confidence interval for each estimate will be obtained from the bootstrap samples and the difference in the estimates between the imaging modalities will be compared by the Wald test with the standard error calculated from the bootstrap samples.
Measured: Baseline, post ablation, and disease progression, an average of 3.87 months
Lesion Level Specificity
Lesion level specificity is defined as true negative (TN)/[TN+ false positive (FP], being TN = true negative (i.e., positron emission tomography (PET) negative lesions that are histopathologically negative, and FP = false positive (i.e., PET positive lesions that are histopathologically negative). The lesion level specificity of piflufolastat F-18 (18F-DCFPyL) positron emission tomography scan and a computed tomography (PET/CT) and CT/magnetic resonance imaging (MRI) will be calculated and compared. The confidence interval for each estimate will be obtained from the bootstrap samples and the difference in the estimates between the imaging modalities will be compared by the Wald test with the standard error calculated from the bootstrap samples.
Measured: Baseline, post ablation, and disease progression, an average of 3.87 months
Lesion Level Positive Predictive Value
Lesion level positive predictive value is defined as true positive (TP/[TP+ false positive (FP], being TP = true positive (i.e., positron emission tomography (PET) positive lesions that are histopathologically positive) and FP = false positive (i.e., PET positive lesions that are histopathologically negative) . The lesion level positive predictive value of piflufolastat F-18 (18F-DCFPyL) positron emission tomography scan and a computed tomography (PET/CT) and CT/magnetic resonance imaging (MRI) will be calculated and compared. The confidence interval for each estimate will be obtained from the bootstrap samples and the difference in the estimates between the imaging modalities will be compared by the Wald test with the standard error calculated from the bootstrap samples.
Measured: Baseline, post ablation, and disease progression, an average of 3.87 months
Change in Piflufolastat F-18 (18F-DCFPyL) Positron Emission Tomography and Computed Tomography (PET/CT) Maximum Standardized Uptake Value (SUVmax) Between Pre- and Post-treatment
Change in 18F-DCFPyL PET/CT maximum standardized uptake value (SUVmax) between pre- and post-treatment tumor or tumor bed will be compared by paired Wilcoxon test for participants who undergo local treatment for hepatocellular carcinoma. Positive uptake is defined as a focal abnormal area of increased 18F-DCFPyL activity higher than the surrounding liver uptake standard update value (SUV)max more than x 1.2 times than the normal liver-SUV mean). Negative uptake is defined as tumor uptake less than adjacent background soft tissue, or less than blood pool for lymph nodes.
Measured: Pre- and post-treatment hepatocellular carcinoma (HCC) 18F-DCFPyL PET scans, an average of 3.2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start18 Jan 2023
- Primary completion14 Nov 2024
- Study completion20 Nov 2024
Why it stopped: Reason for termination was a combination of slow accrual in setting of austerity measures regarding resource allocation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Esther Mena, M.D., National Cancer Institute (NCI)
- Investigators
- Esther Mena Gonzalez, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009979
- Sponsor's protocol ID
- 10000080
- Other IDs
- 000080-C
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2021
- Last updated
- 28 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
Publications
Mena E, Shih J, Chung JY, Jones J, Rabiee A, Monge C, Turkbey B, Lindenberg L, Salerno KE, Kassin M, Wood B, Hernandez J, Maass-Moreno R, Saboury B, Jakhete N, Molitoris JK, Unger KR, Choyke PL, Escorcia FE. Functional Imaging of Liver Cancer (FLIC): Study protocol of a phase 2 trial of 18F-DCFPyL PET/CT imaging for patients with hepatocellular carcinoma. PLoS One. 2022 Nov 11;17(11):e0277407. doi: 10.1371/journal.pone.0277407. eCollection 2022.
PubMed 36367894
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-DCFPyL PET/CT in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05009979
- Acronym / sponsor ID
- 10000080
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Imaging, Liver Cancer, Radiotracer, PSMA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Reason for termination was a combination of slow accrual in setting of austerity measures regarding resource allocation.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Posted 28 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
A radiotracer (or tracer) is a radioactive substance. It is used in Positron Emission Tomography (PET) imaging to help see specific sites in the body. Researchers want to learn if a new tracer can help them better identify hepatocellular cancer (HCC) in people.
Objective:
To learn if a radiotracer called piflufolastat F-18 (18F-DCFPyL), can identify sites of HCC better than current standard imaging.
Eligibility:
Adults aged 18 years and older who may have HCC based on previous standard imaging.
Design:
Participants will be screened with a medical history, physical exam, and blood tests. They will have a computed tomography (CT) and/or magnetic resonance imaging (MRI) scan.
Participants will have a whole-body positron emission tomography (PET/CT) scan. The PET and CT scanners use x-rays to make pictures of the inside of the body. The PET uses a tracer to help make the pictures. Participants will get an intravenous (IV) injection of 18F-DCFPyL 1 hour before the scan.
Within two weeks, participants will have a Fludeoxyglucose F 18 (18F-FDG) PET/CT scan. 18F-FDG is a commonly used tracer. They will get 18F-FDG via IV 1 hour before the scan.
Participants will have a CT/magnetic resonance imaging (MRI) within 2 months of the first 18F-DCFPyL PET/CT.
Participants will have standard treatment for their cancer. During treatment, they will have a tumor biopsy. If the biopsy shows they do not have HCC, they will be removed from the study.
For participants who have HCC and their cancer was identified in the 18F-DCFPyL PET/CT, they will have a second 18F-DCFPyL PET/CT and 18F-FDG PET/CT.
Participants will have follow-up visits every 3 months for 2 years. Then they will have yearly visits for 3 years.
Detailed description
Background:
Prostate specific membrane antigen is overexpressed in high-grade tumors, and increases when de-differentiation, metastatic or hormone-refractory disease occur, making the expression level a prognostic factor for disease outcome.
It has been shown that prostate-specific membrane antigen (PSMA) can be expressed not only on prostate cancer cells, but also on cell lines of other malignancies, as well as tumor endothelium.
A recent publication reported that nearly 95% of hepatocellular carcinoma (HCC) stained positive for PSMA in the tumor vasculature. Research suggests that the process of endothelial cell recruitment to HCC occurs early and throughout the process of hepatic tumorigenesis, making an endothelial cell tracer an ideal marker to detect early disease.
18F-DCFPyL, a second generation PSMA PET agent, binds with high affinity to PSMA yet clears rapidly from the blood pool and thus, whole-body PET imaging with this agent, may provide a new tool in staging high risk cancers and detecting recurrent disease.
We propose to expand our clinical work using 18F-DCFPyL and evaluate its usefulness for detecting sites of hepatocellular carcinoma.
Objective:
To assess the ability of 18F-DCFPyL PET/CT imaging to detect sites of hepatocellular carcinoma
Eligibility:
Participants >= 18 years old
High radiological suspicion of hepatocellular carcinoma (HCC) with at least one measurable lesion on standard imaging modality (CT and/or MRI)
Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2
Design:
This is a multi-site imaging study enrolling participants with suspected hepatocellular carcinoma. The accrual ceiling is set to 50 participants.
All participants will undergo a baseline 18F-DCFPyL PET/CT scan. A standard of care CT and/or MRI will be performed within 2 months of the 18F-DCFPyL PET/CT. Participants will be also scanned with an 18F-FDG PET/CT imaging within approximately 2 weeks of the 18F-DCFPyL PET/CT imaging.
Participants will be scheduled to undergo a biopsy prior to or during standard of care local treatment for HCC (e.g., resection, radiofrequency ablation, microwave ablation, transarterial embolization (TAE), stereotactic body radiotherapy (SBRT)).
Participants with a baseline positive 18F-DCFPyL-PET/CT imaging (i.e. with the presence of DCFPyL-avid tumor/s) and biopsy confirming HCC diagnosis will undergo a post-treatment 18F-DCFPyL PET/CT imaging during the first routine follow-up period, typically within 16 weeks. Subjects with negative tumor uptake at baseline 18F-DCFPyL-PET/CT will not be re-scanned post-treatment but will remain in follow-up.
Participants with a positive HCC biopsy will be followed for 5 years to assess progression free survival.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1, Cohort 1 Baseline and Post-treatment Imaging with Piflufolastat F-18 (18F-DCFPyL) | Experimental | Drug: F18-FDG, Device: MRI, Device: CT, Drug: F18-DCFPyL, Procedure: Tumor biopsyPiflufolastat 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- High radiological suspicion of hepatocellular carcinoma (LR4 (probably hepatocellular carcinoma) or LR5 (definitely hepatocellular carcinoma) based on the most current version of Liver Imaging Reporting \& Data System (LI-RADS) with at least one measurable lesion on standard imaging modality computed tomography (CT) and/or magnetic resonance imaging (MRI).
- Eligible for local therapies (included but not limited to surgical resection, stereotactic radiation therapy, transarterial chem/radio/bland embolization, microwave ablation, radiofrequency ablation).
- Ability to take oral medication and be willing to adhere to the study intervention regimen.
- Age >=18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status <=2.
Key exclusion criteria (7 listed)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-DCFPyL, or other agents used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects with severe claustrophobia unresponsive to oral anxiolytics.
- Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures.
- Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F18-FDGAlso: Fludeoxyglucose F 18Within approximately 2 weeks of each piflufolastat F-18 (18F-DCFPyL) positron emission tomography/ computed tomography (PET/CT) scan, participants will be scanned with a fludeoxyglucose F 18 (18F-FDG) PET/CT imaging at the NIH Clinical Center using standard procedures. The 18F-FDG PET/CT imaging performed will allow the localization of viable tumor sites and characterize their FDG metabolism for comparison with 18F-DCFPyL imaging. The 18F-FDG PET/CT imaging will consist of an 18F-FDG injection and PET/CT imaging performed approximately 1 hour post 18F-FDG injection. A corresponding low dose CT scan for attenuation correction and co-registration purposes will be performed prior to the PET image. | Drug | Arm 1, Cohort 1 Baseline and Post-treatment Imaging with Piflufolastat F-18 (18F-DCFPyL) |
| MRIAlso: Magnetic resonance imagingA standard of care computed tomography (CT) and/or magnetic resonance imaging (MRI) will be performed within 2 months of each piflufolastat F-18 (18F-DCFPyL) positron emission tomography (PET/CT). | Device | Arm 1, Cohort 1 Baseline and Post-treatment Imaging with Piflufolastat F-18 (18F-DCFPyL) |
| CTAlso: Computed tomographyA standard of care computed tomography (CT) and/or magnetic resonance imaging (MRI) will be performed within 2 months of each piflufolastat F-18 (18F-DCFPyL) positron emission tomography (PET/CT). | Device | Arm 1, Cohort 1 Baseline and Post-treatment Imaging with Piflufolastat F-18 (18F-DCFPyL) |
| F18-DCFPyLAlso: piflufolastat F-18Each subject will receive a single intravenous (IV) dose of piflufolastat F-18 (18F-DCFPyL) by bolus injection at a rate of approximately 1 ml/3-5 sec. The maximum amount of injected active drug will be less than 4.02 microgram. The target administered activity will be 9 mCi. The 18F-DCFPyL positron emission tomography and computed tomography (PET/CT) imaging will consist of the 18F-DCFPyL injection, followed by approximately 45 min dynamic CT imaging of a single bed position (including the liver lesion), and a static whole-body PET/CT imaging (top of head to mid-thighs) performed at 1 hour (+/-10 minutes) post 18F-DCFPyL injection. Only a single injection of 18F-DCFPyL is required. The initial 45 minutes dynamic regional scan will be used to determine the kinetics of 18F-DCFPyL within the tumor as compared with normal liver and other background. | Drug | Arm 1, Cohort 1 Baseline and Post-treatment Imaging with Piflufolastat F-18 (18F-DCFPyL) |
| Tumor biopsyPrincipal investigator discretion pre-treatment or during surgical resection. | Procedure or surgery | Arm 1, Cohort 1 Baseline and Post-treatment Imaging with Piflufolastat F-18 (18F-DCFPyL) |
Primary outcome
Positive Predictive Value (PPV) Defined as the Proportion of Histopathology Positive Lesions as Measured by the Maximum Standardized Uptake (SUVmax) Value
Time frame: Baseline, post ablation, and disease progression, an average of 3.87 months
Positive predictive value is defined as the proportion of histopathologically positive lesions. Positron emission tomography (PET) positivity was measured by the maximum standardized uptake (SUVmax) value. The 95% confidence intervals of the positive predictive value of piflufolastat F-18 (18F-DCFPyL) positron emission tomography scan and computed tomography (PET/CT) will be reported in which the confidence limits are the 2.5th and 97.5th percentile of the 2000 bootstrap samples obtained by random sample without replacement at the participant level to account for inter-lesion correlation. For lesions within the liver, a focal abnormal area of increased 18F-DCFPyL activity higher than the surrounding liver uptake (SUVmax more than x 1.2 times than the normal liver-SUV mean) will be considered positive. For lesions outside the liver, a positive lesion is defined as focal abnormal uptake higher than the blood pool or surrounding normal organ or soft tissue background.
Point Estimates of the Positive Predictive Value of Piflufolastat F-18 (18F-DCFPyL)
Time frame: Baseline, post ablation, disease progression, an average of 3.87 months
Positive predictive value of the DCFPyL PET imaging agent is defined as the proportion of radiologically positive lesions (true positives) that were PET positive, over the radiologically (CT/MRI) positive lesions that were PET positive (true positives) added to the radiologically negative lesions that were PET positive (false positives). Point estimates and 95% confidence intervals of the positive predictive values of piflufolastat F-18 (18F-DCFPyL) positron emission tomography scan and computed tomography (PET/CT) will be reported in which the confidence limits are the 2.5th and 97.5th percentile of the 2000 bootstrap samples obtained by random sample without replacement at the participant level to account for inter-lesion correlation.
4 secondary outcomes
Lesion Level Sensitivity
Time frame: Baseline, post ablation, and disease progression, an average of 3.87 months
Lesion Level Specificity
Time frame: Baseline, post ablation, and disease progression, an average of 3.87 months
Lesion Level Positive Predictive Value
Time frame: Baseline, post ablation, and disease progression, an average of 3.87 months
Change in Piflufolastat F-18 (18F-DCFPyL) Positron Emission Tomography and Computed Tomography (PET/CT) Maximum Standardized Uptake Value (SUVmax) Between Pre- and Post-treatment
Time frame: Pre- and post-treatment hepatocellular carcinoma (HCC) 18F-DCFPyL PET scans, an average of 3.2 months.
Results and safety
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Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36367894Mena E, Shih J, Chung JY, Jones J, Rabiee A, Monge C, Turkbey B, Lindenberg L, Salerno KE, Kassin M, Wood B, Hernandez J, Maass-Moreno R, Saboury B, Jakhete N, Molitoris JK, Unger KR, Choyke PL, Escorcia FE. Functional Imaging of Liver Cancer (FLIC): Study protocol of a phase 2 trial of 18F-DCFPyL PET/CT imaging for patients with hepatocellular carcinoma. PLoS One. 2022 Nov 11;17(11):e0277407. doi: 10.1371/journal.pone.0277407. eCollection 2022.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Mena Gonzalez, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing F18-FDG, MRI and CT in people with Hepatocellular Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Predictive Value (PPV) Defined as the Proportion of Histopathology Positive Lesions as Measured by the Maximum Standardized Uptake (SUVmax) Value (time frame: Baseline, post ablation, and disease progression, an average of 3.87 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05009979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.