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 gastric, gastroesophageal junction or esophageal cancer. 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 gastric or esophageal cancers.
Helios CR Inc./RadNet
Cerritos, California, United States
RECRUITINGCity of Hope National Cancer Center
Duarte, California, United States
RECRUITINGHoag Memorial Hospital
Irvine, California, United States
RECRUITINGUCLA
Los Angeles, California, United States
RECRUITINGStanford University
Stanford, California, United States
RECRUITINGMoffit Cancer Center
Tampa, Florida, United States
RECRUITINGIndiana University Health University Hospital
Indianapolis, Indiana, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGUMass/Shields
Worcester, Massachusetts, United States
RECRUITINGMayo Clinic Rochester
Rochester, Minnesota, United States
RECRUITING...and 6 more locations
Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference
To evaluate the diagnostic performance of \[¹⁸F\]FAPI-74 in determining the presence or absence of metastatic disease (M1) in individuals with pathologically confirmed gastric, gastroesophageal junction or esophageal cancers, compared to a composite SOT
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.
Time frame: 24-72 hours post-injection
Sensitivity and specificity for the localized detection of peritoneal metastases
To evaluate the diagnostic performance of \[18F\]FAPI-74 PET/CT for detecting peritoneal metastatic disease
Time frame: From enrollment to the end of treatment after 3 month follow up
Comparative sensitivity and specificity between [18F]FAPI-74 and [¹⁸F]FDG PET/CT for detection of M1 disease using a composite SOT as reference
To compare clinical accuracy of \[18F\]FAPI-74 PET/CT imaging to that of \[¹⁸F\]FDG PET/CT, for participants who have had this performed, for detection of metastatic disease.
Time frame: From enrollment to the end of treatment after 3 month follow up
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
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: 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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