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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with pancreatic ductal adenocarcinoma receiving [18F]FAPI-74 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]FAPI-74 PET/CT | Drug | [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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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: From enrollment to the end of treatment after 3 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events using CTCAE v5. | To assess the safety profile of [¹⁸F]FAPI-74 PET/CT. | 24-72 hours post-injection |
| Cohen's kappa for pairwise evaluation of inter- and intra-reader agreement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Osipova | Contact | 1-800-753-5368 | Alex.osipova@sofie.com | |
| Bridget Adams | Contact | 1-800-753-5368 | bridget.adams@sofie.com |
| Name | Affiliation | Role |
|---|---|---|
| Sherly Mosessian, Ph.D | Sofie Co. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helios CR Inc./RadNet | Recruiting | Cerritos | California | 90703 | United States |
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To assess inter-and intra-reader variability in image interpretation of the presence of metastatic disease
| 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. | 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 | 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 | 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 | 24-72 hours post-injection |
| City of Hope National Cancer Center | Recruiting | Duarte | California | 91010 | United States |
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| Hoag Memorial Hospital | Recruiting | Irvine | California | 92618 | United States |
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| UCLA | Recruiting | Los Angeles | California | 90095 | United States |
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| Stanford University | Recruiting | Stanford | California | 94305 | United States |
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| Moffit Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| Indiana University Health University Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| UMass/Shields | Recruiting | Worcester | Massachusetts | 01655 | United States |
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| Mayo Clinic Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Icahn School of Medicine at Mount Sinai | Not yet recruiting | New York | New York | 10029 | United States |
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| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Kettering | Recruiting | Kettering | Ohio | 45429 | United States |
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| University of Pennsylvania, Perelman School of Medicine | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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