18F-DCFPyL PET/CT in Hepatocellular Carcinoma

Status: administratively complete

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.

Inclusion Criteria

- 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.

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.

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18F-DCFPyL PET/CT in Hepatocellular Carcinoma

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