Clinical trial · Interventional
18F-DCFPyL PET/CT in Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Reason for termination was a combination of slow accrual in setting of austerity measures regarding resource allocation.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT | Device | — | UNRESOLVED |
| F18-DCFPyL | Drug | — | UNRESOLVED |
| F18-FDG | Drug | — | UNRESOLVED |
| MRI | Device | — | UNRESOLVED |
| Tumor biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1, Cohort 1 Baseline and Post-treatment Imaging with Piflufolastat F-18 (18F-DCFPyL)
- description
- 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
- interventionNames
- Drug: F18-FDG
- Device: MRI
- Device: CT
- Drug: F18-DCFPyL
- Procedure: Tumor biopsy
Primary outcomes (2)
- measure
- Positive Predictive Value (PPV) Defined as the Proportion of Histopathology Positive Lesions as Measured by the Maximum Standardized Uptake (SUVmax) Value
- timeFrame
- Baseline, post ablation, and disease progression, an average of 3.87 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* INCLUSION CRITERIA: * 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. * 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 EXCLUSION CRITERIA: * 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.
References
Publications (1)
- DERIVEDMena 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. PMID 36367894