Using a new imaging agent to detect various cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a new PET imaging agent, [18F]FAPI-74, in detecting certain cancers compared to standard imaging methods. Participants aged 18 and older with specific types of cancer will undergo two baseline scans: one with [18F]FAPI-74 and another with an approved tracer. The goal is to determine if [18F]FAPI-74 can more accurately highlight tumors that express fibroblast activation protein (FAP), which is associated with poor prognosis in cancer. This study is being conducted at the National Institutes of Health Clinical Center.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA:
* 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 CRITERIA:

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Esther Mena Gonzalez, M.D. — National Cancer Institute (NCI)
• Study coordinator: Yolanda L McKinney, R.N.
• Email: ymckinney@mail.nih.gov
• Phone: (240) 760-6095

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.