18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection
NCT ID: NCT06503146
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
320 participants
INTERVENTIONAL
2025-09-09
2030-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Fibroblast-activation protein (FAP) is an enzyme that appears in high numbers in cancer-associated fibroblasts of certain cancer types. \[18F\]FAPI-74 is a new PET (positron emission tomography) tracer, a substance that is injected into a person s body before an imaging scan. Researchers believe that \[18F\]FAPI-74 PET imaging may be able to visualize cancer more effectively than the approved tracers. If so, the new tracer would make it easier to find FAP-positive tumors in the body.
Objective:
To see if \[18F\]FAPI-74 PET scan is as good or better than other imaging methods for detecting certain cancers.
Eligibility:
People aged 18 years or older with one of these cancer types: pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, hepatocellular carcinoma (HCC), gastric cancer, bladder cancer, ovarian cancer, pheochromocytoma/paraganglioma (PPGL), small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancer (EP-NEC), mesothelioma or sarcoma. Participants must be scheduled or intended to receive treatment for cancer.
Design:
Participants will have 2 baseline scans: an \[18F\]FAPI-74, and the approved tracer \[18F\]-FDG.
The \[18F\]FAPI-74 will be infused through a needle inserted into a vein. About 1 hour later, the participant will undergo imaging.
Within 1 week, participants will undergo the same scanning procedures with the approved tracer.
If the baseline scan with \[18F\]FAPI-74 shows the tumor(s), scans with this tracer will be repeated when their regular treatment regimen calls for scans again. If the scan with the regular FDG also show tumors, this scan will be repeated within the same week as the repeated \[18F\]FAPI-74 scan. If \[18F\]-FAPi PET scan shows no tumor(s), scans will not be repeated.
If the participant's cancer progresses within 2 years, scans may be repeated.
Follow-up calls will continue for 2 years.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Fibroblast-activation protein (FAP) is a transmembrane type 2 serine protease with dipeptidyl peptidase and endopeptidase activity that is overexpressed on the surface of cancer-associated fibroblasts (CAFs), a major constituent of the tumor stroma, which correlates with a poor prognosis.
* FAP-positive CAFs are present in the stromal tissue of more than 90% of epithelial carcinomas, including pancreatic, colorectal, ovarian, lung, and breast cancer among others.
* FAP has emerged in recent years as a promising target for molecular imaging with PET/Computed Tomography (CT), using radiolabeled FAP inhibitors (FAPI). FAPI labeled with 68Ga or 18F has shown great promise in cancer detection demonstrating high tumor-to-background ratios in patients across a wide array of cancers.
* While there is much clinical data with 68Ga-FAPI, there is much less data on the efficacy of \[18F\]FAPI-74, which is a more practical version of this PET agent due to its longer half-life.
Objective:
-To compare \[18F\]FAPI-74 PET imaging to 18F-fluorodeoxyglucose (18F-FDG) PET imaging and other imaging considered standard of care (SOC) (e.g., CT, and/or magnetic resonance imaging \[MRI\]) to detect sites of cancer in several malignancies.
Eligibility:
* \>= 18 years old.
* Histologically confirmed pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, hepatocellular carcinoma (HCC), gastric cancer, bladder cancer, ovarian cancer, or pheochromocytoma/paraganglioma (PPGL), small cell lung or extrapulmonary neuroendocrine cancer, mesothelioma or sarcoma.
* Eastern Cooperative Oncology Group (ECOG) Performance score \<= 2.
Design:
* This is a single-site imaging study enrolling participants with PDAC, cholangiocarcinoma, HCC, gastric cancer, bladder cancer, ovarian cancer, pheochromocytoma/paraganglioma, small cell lung or extrapulmonary neuroendocrine cancers, mesothelioma or sarcoma.
* All participants will undergo baseline \[18F\]FAPI-74 PET and 18F-FDG PET imaging.
* Participants with a positive baseline \[18F\]FAPI-74 PET scan (i.e., with the presence of FAPIpositive tumor/s) will undergo the second \[18F\]FAPI-74 PET imaging at the time of the next re-staging. Participants with a negative baseline \[18F\]FAPI-74 PET scan will not have post-treatment \[18F\]FAPI-74 PET or 18F-FDG PET scans performed on this protocol but will remain in follow-up.
* Participants with a negative baseline 18F-FDG PET scan will not be re-scanned with 18F-FDG PET but may be re-scanned with \[18F\]FAPI-74 PET if baseline \[18F\]FAPI-74 PET imaging is positive.
* All participants will be followed for 2 years following the first \[18F\]FAPI-74 PET scan to assess progression-free survival and 2-year overall survival. During this period, participants may undergo the additional \[18F\]FAPI-74 and 18F-FDG PET imaging in case of suspicion for recurrence/disease progression. These scans may be done even if the baseline \[18F\]FAPI-74 and/or 18F-FDG PET imaging are negative.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1/Arm 1
\[18F\]FAPI-74 and 18F-FDG PET imaging
[18F]FAPI-74
Participants will receive a single intravenous (IV) dose of \[18F\]FAPI-74 prior to PET/CT imaging.
[18F]FDG
18F-FDG PET/CT or PET/MRI imaging will be done per standard of care.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
[18F]FAPI-74
Participants will receive a single intravenous (IV) dose of \[18F\]FAPI-74 prior to PET/CT imaging.
[18F]FDG
18F-FDG PET/CT or PET/MRI imaging will be done per standard of care.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants must be scheduled or intended to receive treatment for their cancer.
* Evaluable disease
* \>= 18 years old.
* Eastern Cooperative Oncology Group (ECOG) performance score \<= 2.
* Individuals of child-bearing potential (IOCBP) and individuals that can father children must agree to use effective contraception (barrier, hormonal, intrauterine device (IUD), surgical sterilization, abstinence) at the study entry and for 2 months after each (18F) FAPI-74 imaging. Sperm may not be frozen or donated within the same period.
* Must be willing to discontinue breastfeeding for 2 months after each study imaging.
* The ability of participant to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
* History of severe claustrophobia unresponsive to oral anxiolytics or history of any other condition preventing the ability to lie on the imaging scanner for up to 45 minutes.
* Weight \> 350 lbs., or inability to fit within the imaging gantry.
* Positive Beta-human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in IOCBP at screening.
* Uncontrolled intercurrent illness, or medical condition(s) including but not limited to renal failure, liver failure, or psychiatric illness/social situations evaluated by medical history and physical exam that would limit compliance with study requirements and potentially increase risk for the participant.
* Serum creatinine \> 2 times the upper limit of normal.
* Liver transaminases (ALT, AST) greater than 3 times the upper limit of normal.
18 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Esther Mena Gonzalez, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
National Cancer Institute Referral Office
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
NIH Clinical Center Detailed Web Page
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
001731-C
Identifier Type: -
Identifier Source: secondary_id
10001731
Identifier Type: -
Identifier Source: org_study_id