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Imaging for Cancer Detection with [18F]FAPI-74

This study is looking at a new imaging method using a substance called [18F]FAPI-74 (a PET tracer) to find certain cancers. Researchers believe this new tracer might be better at finding tumors than current methods. You could be eligible if you are 18 or older and have a confirmed diagnosis of pancreatic, cholangiocarcinoma, hepatocellular, gastric, bladder, ovarian cancer, pheochromocytoma/paraganglioma (PPGL), small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancer (EP-NEC), mesothelioma, or sarcoma. The main goal is to see if [18F]FAPI-74 PET scans are as good as or better than other imaging tests at detecting cancer sites. The study plans to enroll 320 participants.

Study design
This interventional study plans to enroll 320 participants. It compares [18F]FAPI-74 PET imaging to standard imaging methods.
What's involved
Participants will receive a single intravenous (IV) dose of [18F]FAPI-74 before a PET/CT scan. You will also have an [18F]FDG PET/CT or PET/MRI scan as part of your standard care.
Compensation
Not stated in the trial record.
Follow-up
The number of lesions will be measured at the start of the study, after treatment, and if the cancer returns.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06503146

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
National Cancer Institute (NCI)
~320 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:[18F]FAPI-74[18F]FDG

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean number of lesions
Measured over Baseline, post-treatment and recurrence

Conditions

Sarcoma
Small Cell Lung Cancer or Extrapulmonary Neuroendocrine Cancer (EP-NEC)
Mesothelioma
Pheochromocytoma/Paraganglioma (PPGL)
Pancreatic Ductal Adenocarcinoma
Ovarian Cancer
Hepatocellular Carcinoma
Gastric Cancer
Cholangiocarcinoma
Bladder Cancer

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Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Esther Mena Gonzalez, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Yolanda L McKinney, R.N.
[email protected]
(240) 760-6095
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically confirmed 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 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

History of allergic reactions attributed to compounds of similar chemical or biologic composition to \[18F\]FAPI-74 or other agents used in the study.
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.

What this trial measures

  • Mean number of lesionsBaseline, post-treatment and recurrence

    The mean number of lesions detected will be compared between the different scan modalities for each cancer type.