18F-DCFPyL PET/CT in Hepatocellular Carcinoma
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ClinicalTrials.gov Identifier: NCT05009979 |
Recruitment Status :
Recruiting
First Posted : August 18, 2021
Last Update Posted : May 16, 2024
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | August 17, 2021 | ||||||||||||||
First Posted Date ICMJE | August 18, 2021 | ||||||||||||||
Last Update Posted Date | May 16, 2024 | ||||||||||||||
Actual Study Start Date ICMJE | January 18, 2023 | ||||||||||||||
Estimated Primary Completion Date | June 1, 2025 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Positive predictive value [ Time Frame: Baseline, post ablation, disease progression ] 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | 18F-DCFPyL PET/CT in Hepatocellular Carcinoma | ||||||||||||||
Official Title ICMJE | 18F-DCFPyL PET/CT in Hepatocellular Carcinoma | ||||||||||||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Hepatocellular Carcinoma | ||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: 1/Baseline and Post-treatment Imaging
18F-DCFPyL PET/CT imaging, CT and/or MRI and standard of care local ablative treatment
Interventions:
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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. | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||
Estimated Enrollment ICMJE |
50 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Estimated Study Completion Date ICMJE | December 1, 2025 | ||||||||||||||
Estimated Primary Completion Date | June 1, 2025 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE |
EXCLUSION CRITERIA:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||
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Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT05009979 | ||||||||||||||
Other Study ID Numbers ICMJE | 10000080 000080-C |
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Has Data Monitoring Committee | Not Provided | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) | ||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||
Current Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||
Investigators ICMJE |
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PRS Account | National Institutes of Health Clinical Center (CC) | ||||||||||||||
Verification Date | May 6, 2024 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |