This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of \[¹⁸F\]FAPI-74 PET/CT in the detection of metastatic disease in individuals with pathologically confirmed pancreatic ductal adenocarcinoma. Following screening, using a standardized administration protocol and dose, participants will undergo \[¹⁸F\]FAPI-74 PET/CT screening. SOC procedures and interventions will be captured during 3 months +/-14 days post injection. The primary objective is to evaluate the sensitivity and specificity of such \[¹⁸F\]FAPI-74 PET/CT using a composite SOT panel. The maximum expected duration of the trial is approximately 24 months from first patient screening to last patient SOC follow up. The participants will be followed-up for safety for 24 to 72 hours after the dose of \[¹⁸F\]FAPI-74 PET/CT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
\[18F\]FAPI-74 is a radioactive diagnostic agent indicated for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF) in patients with pancreatic ductal adenocarcinoma.
Helios CR Inc./RadNet
Cerritos, California, United States
RECRUITINGHoag Memorial Hospital
Irvine, California, United States
RECRUITINGIndiana University Health University Hospital
Indianapolis, Indiana, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGUMass/Shields
Worcester, Massachusetts, United States
NOT_YET_RECRUITINGKettering
Kettering, Ohio, United States
RECRUITINGSensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference
To evaluate the diagnostic performance of \[¹⁸F\]FAPI-74 PET/CT scan in determining the presence or absence of metastatic disease (M1) in patients with pancreatic ductal adenocarcinoma compared with a composite standard of truth (SOT).
Time frame: Time Frame: From enrollment to the end of treatment after 3 month follow up
Incidence and severity of adverse events using CTCAE v5.
To assess the safety profile of \[¹⁸F\]FAPI-74 PET/CT.
Time frame: 24-72 hours post-injection
Cohen's kappa for pairwise evaluation of inter- and intra-reader agreement
To assess inter-and intra-reader variability in image interpretation of the presence of metastatic disease
Time frame: From enrollment to the end of treatment after 3 month follow up
Number of participants with treatment-related adverse events as assessed by body temperature changes
To assess the safety profile of \[¹⁸F\]FAPI-74 PET/CT.
Time frame: 24-72 hours post-injection
Number of participants with treatment-related adverse events as assessed by blood pressure changes
To assess the safety profile of \[¹⁸F\]FAPI-74
Time frame: 24-72 hours post-injection
Number of participants with treatment-related adverse events as assessed by respiration rate
To assess the safety profile of \[¹⁸F\]FAPI-74
Time frame: 24-72 hours post-injection
Number of participants with treatment-related adverse events as assessed by pulse rate
To assess the safety profile of \[¹⁸F\]FAPI-74
Time frame: 24-72 hours post-injection
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