Using a new imaging agent to detect various cancers
18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection
PHASE2 · National Institutes of Health Clinical Center (CC) · NCT06503146
This study is testing a new imaging agent to see if it can better detect certain cancers in adults compared to standard imaging methods.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06503146 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed pancreatic ductal adenocarcinoma, cholangiocarcinoma, hepatocellular carcinoma, gastric cancer, bladder cancer, or other specified malignancies.
Not a fit: Patients without a confirmed diagnosis of the specified cancers or those not enrolled in an NIH treatment study may not benefit from this trial.
Why it matters
Potential benefit: If successful, this imaging technique could lead to earlier and more accurate detection of various cancers, improving treatment outcomes.
How similar studies have performed: Previous studies using similar imaging approaches have shown promise, but the efficacy of [18F]FAPI-74 specifically is less established, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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 this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sarcoma, Small Cell Lung Cancer or Extrapulmonary Neuroendocrine Cancer, Mesothelioma, Pheochromocytoma/Paraganglioma, Pancreatic Ductal Adenocarcinoma, Ovarian Cancer, Hepatocellular Carcinoma, Gastric Cancer