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18F-DCFPyL PET/CT in Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

F18-FDG

MRI

F18-DCFPyL

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring Imaging, Liver Cancer, Radiotracer, PSMA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA:
High radiological suspicion of hepatocellular carcinoma (LR4 or LR5 based on the most current version of LI-RADS) with at least one measurable lesion on standard imaging modality (CT and/or 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.
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 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 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.

Sites / Locations

National Institutes of Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1/Baseline and Post-treatment Imaging

Arm Description

18F-DCFPyL PET/CT imaging, CT and/or MRI and standard of care local ablative treatment

Outcomes

Primary Outcome Measures

Positive predictive value

The point estimates and 95% confidence intervals of the positive predictive value of 18F-DCFPyL 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.

Secondary Outcome Measures

Lesion level sensitivity, specificity and positive predictive value

The lesion level sensitivity, specificity and positive predictive value of 18F-DCFPyL PET/CT and CT/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.

Change in 18F-DCFPyL PET/CT uptake between pre- and post-treatment

change in 18F-DCFPyL PET/CT uptake between pre- and post-treatment will be compared by paired Wilcoxon test.

Full Information

NCT ID

NCT05009979

First Posted

August 17, 2021

Last Updated

October 20, 2023

Sponsor

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT05009979

Brief Title

18F-DCFPyL PET/CT in Hepatocellular Carcinoma

Official Title

18F-DCFPyL PET/CT in Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 25, 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 18, 2023 (Actual)

Primary Completion Date

June 1, 2025 (Anticipated)

Study Completion Date

December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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. Objective: To learn if a radiotracer called 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 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 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/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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

Imaging, Liver Cancer, Radiotracer, PSMA

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1/Baseline and Post-treatment Imaging

Arm Type

Experimental

Arm Description

18F-DCFPyL PET/CT imaging, CT and/or MRI and standard of care local ablative treatment

Intervention Type

Drug

Intervention Name(s)

F18-FDG

Intervention Description

Within approximately 2 weeks of each 18F-DCFPyL PET/CT scan, participants will be scanned with a 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.

Intervention Type

Device

Intervention Name(s)

MRI

Intervention Description

A standard of care CT and/or MRI will be performed within 2 months of each 18F-DCFPyL PET/CT.

Intervention Type

Device

Intervention Name(s)

Intervention Description

A standard of care CT and/or MRI will be performed within 2 months of each 18F-DCFPyL PET/CT.

Intervention Type

Drug

Intervention Name(s)

F18-DCFPyL

Intervention Description

Each subject will receive a single IV dose of 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 PET/CT imaging will consist of the 18F-DCFPyL injection, followed by a 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.

Primary Outcome Measure Information:

Title

Positive predictive value

Description

Time Frame

Baseline, post ablation, disease progression

Secondary Outcome Measure Information:

Title

Lesion level sensitivity, specificity and positive predictive value

Description

Time Frame

Baseline, post ablation, disease progression

Title

Change in 18F-DCFPyL PET/CT uptake between pre- and post-treatment

Description

change in 18F-DCFPyL PET/CT uptake between pre- and post-treatment will be compared by paired Wilcoxon test.

Time Frame

Pre- and post-treatment HCC treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA: High radiological suspicion of hepatocellular carcinoma (LR4 or LR5 based on the most current version of LI-RADS) with at least one measurable lesion on standard imaging modality (CT and/or 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. 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 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joy Zou, R.N.

Phone

(240) 760-6153

joy.zou@nih.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Freddy E Escorcia, M.D.

Phone

(240) 858-3062

freddy.escorcia@nih.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Freddy E Escorcia, M.D.

Organizational Affiliation

National Cancer Institute (NCI)

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institutes of Health Clinical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Phone

888-624-1937

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

.All 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 dbGaP.

IPD Sharing Time Frame

Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.

IPD Sharing Access Criteria

Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians.

Citations:

PubMed Identifier

36367894

Citation

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.

Results Reference

derived

Links:

URL

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_000080-C.html

Description

NIH Clinical Center Detailed Web Page

Learn more about this trial

18F-DCFPyL PET/CT in Hepatocellular Carcinoma

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